At the frontiers of science, boundaries are meant to be crossed

In the science of cardiac electrophysiology, there is no sign that says, “Knowledge stops here.” Even if there were, Texas Cardiac Arrhythmia would regard it only as a marker showing the need for continued exploration and discovery.

Research is the heartbeat of the future. That’s why TCA’s staff includes professionals whose only work is to move the science forward. TCA conducts clinical research studies into the refinement of procedures like catheter-based ablation and the development of new technologies like those used in the treatment of heart failure patients.

Leadership in research gives TCA physicians a solid base from which to explore and help shape the future of electrophysiology. It gives TCA patients and people everywhere who have heart rhythm disorders the prospect of improved management of arrhythmia.

TCA. World leadership deep in the heart of Texas.

Advancing the Science: TCA Research Studies

To learn about current TCA research studies, click on any heading.

aMAZE - Left Atrial Appendage Ligation with the LARIAT+®Suture Delivery Systemas Adjunctive Therapy to Pulmonary Vein Isolation for Persistent or Longstanding Persistent Atrial Fibrillation

The left atrial appendage (LAA) is a small sac about the size of your thumb that hangs off the left atrium. It may add to the abnormal heart rhythm of atrial fibrillation (AF). This study is looking at adding the newer non-surgical procedure to close the LAA when combined with catheter ablation for AF. By closing the LAA, it is hoped that this may treat AF more effectively as compared to catheter ablation alone. This study involves a device called the LARIAT+ Suture Delivery System (or “LARIAT”) to close the LAA. The purpose of this study is to evaluate the safety and effectiveness of the LARIAT in subjects with Persistent and Longstanding Persistent AF.

Arrhythmogenic Substrate Evaluation and Ablation in Brugada Syndrome

This study will further investigate electrical conduction associated with Brugada Syndrome, and determine whether ablation may provide protection against VT/VF. In this case-controlled trial, 10 patients with a spontaneous type I Brugada ECG pattern will undergo empiric epicardial electrophysiological mapping and possibly radiofrequency ablation if fragmented epicardial potentials are identified.

AWARE - Impact of anxiety on cardiac substrate modification in woman with atrial fibrillation undergoing catheter ablation

Research studies have suggested an association between anxiety disorders and increased risk of AF. This risk is believed to be attributed to chronic inflammation resulting from anxiety which may cause changes in the heart tissue. These inflammatory changes in the heart tissue may initiate non-PV triggers and scar formation in the left atrium (LA – left upper chamber of the heart). Non-PV triggers and LA scar are known risk factors for recurrence of AF after ablation.

The purpose of this study is to evaluate the impact of anxiety on the heart tissue changes leading to non-PV triggers and LA scar in patients after AF ablation.

BIPOLAR VT - Bipolar Catheter Ablation for the Treatment of Refractory Scar-Related Ventricular Arrhythmia

This is a prospective, multi-center, non-randomized, un-blinded, observational trial for patients who are scheduled to undero treatment for ventricular tachycardia (VT). There are various approaches to treating VT, including ablation. During ablation, heat is usually delivered using a unipolar catheter, in which energy travels from the catheter tip to a grounding pad. This research study seeks to find out if a bipolar ablation catheter, in which the energy travels between two catheter tips on either side of the heart muscle, can be used to eliminate the arrhythmia when the unipolar ablation is unsuccessful.

Boehringer Ingelheim GLORIA - Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients with Atrial Fibrillation

Our research group is collaborating with Texas Heart and Vascular – Austin on this study. This global, multi-center, prospective Registry Program will investigate patients with newly diagnosed non-valvular Atrial Fibrillations (AF) at risk for stroke. The study seeks to investigate the patient characteristics influencing the choice of antithrombotic treatment for the prevention of stroke, and will collect real world data on important antithrombotic treatments for the prevention of stroke. This is an observational study, which means this study will only be collecting information on the medical treatment you are already receiving from your doctor for AF.

Brigham and Women's Hospital CIRT - Cardiovascular Inflammation Reduction Trial

Our research group is collaborating with Texas Heart and Vascular – Austin on this study. This is a randomized, double-blind, placebo-controlled, event-driven trial to determine if methotrexate reduces heart attacks, strokes, or death in people with type 2 diabetes or metabolic syndrome who have already had at least one heart attack or have major blockages in more than one coronary artery found on a heart catheterization.

The U.S. Food and Drug Administration (FDA) has approved methotrexate to treat adults with rheumatoid arthritis and other diseases. However, methotrexate has not been approved to prevent heart attacks and strokes. Therefore, the use of methotrexate in this study is experimental.

CardioFocus Heartlight - Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System–Adaptive Contact

The purpose of this research study is to test the safety and effectiveness of the Cardiofocus Endoscopic Ablation System with Adaptive Contact (EAS-AC) when used to treat atrial fibrillation (AF). The investigational EAS-AC catheter uses laser energy. This differs from standard catheters which use radiofrequency as the energy source. Heat from the laser energy results in the destruction of a portion of the heart muscle that is essential for starting or maintaining the paroxysmal AF (PAF). The study will enroll patients who are scheduled to undergo an ablation procedure to treat AF.

This study is currently in follow-up only and is not enrolling new patients.

CHAMP-HF - Observational Registry of Treatment Patterns in U.S. Heart Failure Patients with Reduced Ejection Fraction

Our research group is collaborating with Texas Heart and Vascular – Austin on this study. This study is sponsored by the pharmaceutical company named Novartis Pharmaceuticals Corporation. Novartis is conducting this non-interventional or observational study to understand how patients with heart failure are treated through evaluation of treatment patterns and reasons for treatment changes.

A non-interventional study is a study in which individuals are observed and certain outcomes are measured. Novartis invites you to join in this non-interventional study. The intention of this study is to provide insight into the treatment patterns of US patients receiving different heart failure treatments. About 5,000 patients in the United States will participate in the study.

This study is currently in follow-up only and is not enrolling new patients.

Chronic Atrial Fibrillation and Exercise Tolerance

The purpose of this study is to determine whether pulmonary vein isolation with radiofrequency ablation will improve exercise capacity and endothelial function in patients with chronic atrial fibrillation. We hypothesize that exercise capacity and endothelial function will improve in patients with chronic atrial fibrillation following pulmonary vein isolation. This pilot study will compare exercise capacity via a treadmill stress test, arterial stiffness, endothelial function, and quality of life before and after PVI ablation.

COGNITION - Mild cognitive impairment (MCI) in patients with atrial fibrillation (AF), trajectories of the progression of MCI and factors associated with the progression

The purpose of this study is to evaluate the incidence of cognitive impairment in AF and compare two treatment strategies: anti-arrhythmic drugs (AADs) and ablation. Questionnaires will be used to evaluate your cognitive status.

CONNECT HF - Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure

The primary objective of this trial is to assess the effect of a quality improvement program and digital technology compared with usual care on heart failure. Patients admitted to the hospital for acute heart failure and reduced left ventricular ejection fraction (LVEF) are enrolled and followed for 1 year.

CVRx Barostim Neo® – Baroreflex Activation Therapy® for Heart Failure

The purpose of this research study is to show whether the Barotim Neo device is safe and works in people with heart failure. The Neo system is a device that is designed to stimulate the body’s natural cardiovascular regulators called baroreceptors, which are in the large blood vessels (carotid arteries) in your neck and potentially improve your heart failure condition. It is believed that when the baroreceptors are stimulated, signals are sent to the brain. The brain then sends signals to the body telling the blood vessels to relax, the heart to slow the heartbeat and stop production of stress-related hormones in the heart, and the kidneys to reduce the amount of fluid in the body.

CyberHeart’s cardiac arrhythmia ablation treatment: Patients with Refractory Ventricular Tachycardia/Fibrillation

This study is a two center, non-randomized, open-label clinical trial that will use the Cyberknife® system and CyberHeart software to treat ventricular tachycardia (VT). The trial is being conducted to learn if this ablation approach is a viable alternative to catheter ablation for arrhythmias (abnormal heart rhythms), especially when conventional therapies with drugs or catheters have either failed or cannot be used. The study will enroll patients that have VT that cannot be treated by standard catheter ablation and have exhausted all conventional therapies for this arrhythmia.

This study is currently in follow-up only and is not enrolling new patients.

DIAMOND AF II - A Prospective Clinical Evaluation of the DiamondTemp™ Ablation System for the Treatment of Persistent Atrial Fibrillation

This study is for patients that are scheduled to undergo Atrial Fibrillation (AF) ablation procedure. The purpose of this clinical study is to see whether the DiamondTemp Ablation catheter System (DiamondTemp) can restore your heart to a normal heart rhythm. DiamondTemp has new technology (network of diamonds in the catheter tip) that allows the tip to be cooled more efficiently. The cooling technology allows for accurate measurement of the heart tissue surface temperature to maintain safe but effective temperatures during ablation. This study will enroll 300 subjects at up to 30 hospitals in the US, Canada, and Europe. Participation will last 12 months.

DIAMOND-AF - A Randomized Controlled Clinical Evaluation of the DiamondTemp™ System for the Treatment of Paroxysmal Atrial Fibrillation

This study is for patients that are scheduled to undergo Atrial Fibrillation (AF) ablation procedure. The purpose of this clinical study is to see whether the DiamondTemp Ablation catheter System (DiamondTemp) can restore your heart to a normal heart rhythm, and is as safe and effective as the TactiCath Quartz Ablation System made by St. Jude Medical.

DiamondTemp has new technology (network of diamonds in the catheter tip) that allows the tip to be cooled more efficiently. The cooling technology allows for accurate measurement of the heart tissue surface temperature to maintain safe but effective temperatures during ablation. Current FDA approved ablation systems use ‘power mode’ vs ‘temperature mode’. DiamondTemp also has ‘split tip technology’ that allows for higher resolution recording which gives the doctor more information.

DiamondTemp is investigational which means it hasn’t been approved by the FDA or other international regulatory authority.

This study is currently in follow-up only and is not enrolling new patients.

ECG Belt for CRT Response

This study will evaluate the Medtronic ECG Belt Research System for patients who are planning to have a cardiac resynchronization therapy (CRT) device implanted. The purpose of this study is to compare the management of CRT patients using the ECG Belt and using routine medical care. The ECG Belt includes an electrode array which wraps around your chest and back and has electrodes on each side. The ECG Belt is temporarily attached to your body for the duration of the visit, and then removed once study testing is complete. About 455 subjects will be in this study in the United States, Canada, and Europe. Participation may last for approximately 9 months.

EnSite Precision - A Clinical Evaluation using EnSite Precision Cardiac Mapping System (software version 2.0.1 or higher) in a Real-World Environment

This clinical study will evaluate the clinical usage of the EnSite Precision™ Cardiac Mapping System and the new software in a variety of procedures and clinical settings for patients with various heart rhythms (arrhythmias). The system is approved by the U.S. Food and Drug Administration (FDA) which means that none of the equipment used in this study is experimental.

This study is currently in follow-up only and is not enrolling new patients.

FIX-HF - Evaluation of the Safety and Efficacy of the OPTIMIZER™ System with Active Fixation Leads in Subjects with Heart Failure Resulting from Systolic Dysfunction

The purpose of this research study is to evaluate the safety and effectiveness of the OPTIMIZER system. The OPTIMIZER system has been developed to improve heart strength by stimulating the heart muscle with an electrical signal. It delivers ‘cardiac contractility modulation’ (CCM) treatment.

This study is currently in follow-up only and is not enrolling new patients.

Half-Normal Saline vs Normal Saline For Irrigation of Open-Irrigated Radiofrequency Catheters in Atrial Fibrillation Ablation

This study will evaluate the safety and effectiveness of two irrigation solutions: the standard normal saline (9 grams per liter of sodium chloride) and half-normal saline (4.5 grams per liter of sodium chloride). During an ablation, your doctor will use an ablation catheter which is irrigated with a saline solution (salt water) to produce a more effective lesion. Usually, ‘normal’ saline is used, which has a salt concentration similar to tears, blood, and other body fluids. Animal studies and infrequent use in humans suggest that using a lower concentration of salt in the irrigation solution may improve the effectiveness of ablation by producing deeper and larger lesions. There are no investigational properties used in this study. All equipment is approved by the FDA

Half-Normal Saline vs Normal Saline for Irrigation of Open-Irrigated Radiofrequency Catheters in Left Ventricular Outflow Tract Arrhythmias Ablation

This study will evaluate the safety and effectiveness of two irrigation solutions: the standard normal saline (9 grams per liter of sodium chloride) and half-normal saline (4.5 grams per liter of sodium chloride). Tachycardia (VT). During this procedure, your doctor will use an ablation catheter which is irrigated with a saline solution (salt water) to produce a more effective lesion. Usually, ‘normal’ saline is used, which has a salt concentration similar to tears, blood, and other body fluids. Animal studies and infrequent use in humans suggest that using a lower concentration of salt in the irrigation solution may improve the effectiveness of ablation by producing deeper and larger lesions. There are no investigational properties used in this study. All equipment is approved by the FDA.

HERITAGE - Heritable Arrhythmia Genetics

The purpose of this study is to evaluate the genetics (the genes and how they are inherited) of the following inheritable arrhythmias: Brugada syndrome, Wolf-Parkinson-White Syndrome, Idiopathic Ventricular Tachycardia and Fibrillation, Long QT Syndrome, Hypertrophic, Dilated and Restrictive Cardiomyopathy and Supraventricular Tachycardia. By studying your DNA, the gene(s) responsible for inherited arrhythmias may be able to be identified. There are no medications or devices being investigated in this study. The study will enroll patients with an inheritable arrhythmia (an abnormal heart rhythm) and participation will last for up to 2 days.

INGEVITY Active Fixation and Passive Fixation Pace/ Sense Lead Study

Our research group is collaborating with Texas Heart and Vascular – Austin on this study. The purpose of this study is to evaluate the safety, performance, and effectiveness of a new lead, called INGEVITY. Standard pacemaker systems consist of a pacemaker device and up to three special wires (leads) that connect the pacemaker to your heart. The pacemaker senses your heart’s own electrical signals and then paces your heart, if it skips a beat, by giving a small electrical impulse through the lead, which you won’t feel. Patients enrolled into this clinical study will have approved indications for a pacemaker or cardiac resynchronization pacemaker (CRT-P) IPG and will be implanted with one or two leads from the INGEVITY Lead family.

This study is currently in follow-up only and is not enrolling new patients.

LESS VT - FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT

The purpose of this study is to show that the FlexAbility™ SE Ablation Catheter (FlexAbility™) is safe and effective in reducing the number of ventricular tachycardia (VT) episodes in patients who continue to experience VT despite taking antiarrhythmic medications, or who are unable to take antiarrhythmic medications. The FlexAbility™ SE Ablation Catheter is approved in the United States to treat irregular heartbeats in the atria (upper chambers of the heart) and is being used in this study to treat irregular heartbeats in the ventricles (lower chambers of the heart).

Involvement will last for 1 year and up to 592 people will participate at up to 35 sites worldwide.

Lifestyle AF - Impact of Lifestyle Modification On Ablation Outcome in Atrial Fibrillation

The purpose of this research study is to evaluate the impact of aggressive lifestyle modification on the outcome of atrial fibrillation (AF) ablation in overweight and obese patients with AF by using diet and exercise. It will enroll patients that have chronic (long term) AF, and are scheduled to undergo an ablation procedure to treat the AF. You will undergo different levels of diet consultation and exercise to determine their effect on the outcome of the ablation procedure.

MAGNETIC-VT - comparing VT ablation outcomes using remote MAGNETIC navigation guided substrate mapping and ablation versus manual approach in a low LVEF population

This prospective, multi-center, post market randomized trial will compare the outcomes of Ventricular Tachycardia (VT) ablation using standard manual placement of the catheter versus magnetic placement of the catheter using the Niobe™ ES MAGNETIC catheter system. This system allows the doctor to remotely maneuver the catheter, rather than move it manually.

The study will enroll patients who are scheduled to undergo an ablation procedure to treat VT and have an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) who have also experiences a myocardial infarction (MI) or ‘heart attach’ that resulted in scar tissue.

All ablation equipment used in this study is approved by the United States Food and Drug Administration (FDA).

Medtronic ADAPT Response Study

A CRT device feature called AdaptivCRT (aCRT) will be evaluated in this study. It is designed to automatically optimize CRT pacing therapy by observing patterns in your heart’s contractions and then automatically adjusting your CRT device settings. Currently, an echocardiogram (ultrasound of the heart) or an ECG (records the electrical tracing of the heart’s activity) may be used to provide information needed to program CRT devices. Another option is to use the standard factory settings. This study will investigate the benefits of the aCRT feature compared to these other methods. The aCRT feature is used in addition to standard CRT therapy.

This study is currently in follow-up only and is not enrolling new patients.

Medtronic Attain StabilityTM Quad Clinical Study

This study is for patients who are receiving a Cardiac Resynchronization Therapy (CRT) system or a CRT system upgrade to treat heart failure. The purpose of this study is to evaluate the safety and efficacy of the investigational Attain Stability Quad MRI SureScan Left Ventricular (LV) Lead. If you participate in the study, you will receive the investigation LV lead. The Attain Stability™ Quad MRI SureScan LV Lead (“study lead”) is similar to other FDA approved LV leads but also has a feature that is used to ensure the lead stays in place.

The Attain Stability Quad Clinical Study is a prospective, non-randomized, multi-site, global, Investigational Device Exemption (IDE) interventional clinical study. This study is currently in follow-up only and is not enrolling new patients.

Medtronic Product Surveillance Registry

The primary purpose of this prospective, non-randomized, multi-center study is to evaluate and publish the long-term reliability and performance of Medtronic market-released cardiac therapy products by analyzing product survival probabilities. Product-related adverse events, indicating the status of the product, will be collected to measure survival probabilities. The data gathered in this study may also be used to support the design and development of investigational plans for new cardiac therapy products.

Medtronic Tachy Prediction Download (TPD) Study

This study will enroll patients who have an Evera MRI Implanted Cardioverter Defibrillator (ICD), and have experienced an abnormal heart rhythm in the lower chamber of the heart known as Ventricular Tachycardia or Ventricular Fibrillation (VT/VF). Current ICDs can only detect VT/VF after it has started. Researchers are working to develop systems to help predict abnormal heart rhythms before they start in order to reduce the need for shock therapy to the heart. The purpose of this study is to collect information from your ICD that may help to develop ways to predict VT/VF before it starts and to create future devices that can prevent it from happening.

NAVIGATE x4 - Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads

The purpose of this research study is to evaluate the safety and effectiveness of the LV lead (ACUITY x4), and RV lead(RELIANCE 4-FRONT), and the CRT-D device (AUTOGEN™ X4CRT-D). For this study, the programmer will use investigational software to communicate with the CRT-D. The study will enroll patients who are scheduled to receive an Implantable Cardioverter Defibrillator (ICD) which provides ‘Cardiac Resynchronization Therapy’ (CRT). The LV lead, CRT-D, and programmer software are investigational, which means they are not approved by the approved by the United States Food and Drug Administration (FDA). The right upper chamber lead used in this study is approved by the FDA and is commercially available.

This study is currently in follow-up only and is not enrolling new patients.

PRECEPT - Prospective Review of the Safety and Effectiveness of the SMARTTOUCH SF Catheter Evaluated for Treating Symptomatic Persistent AF

This is a multicenter, non-randomized clinical evaluation to demonstrate the safety and effectiveness of the ThermoCool SMARTTOUCH SF catheter when used to treat persistent atrial fibrillation (AF). The ablation catheter contains a sensor at the tip that measures pressure the catheter tip exerts on the heart tissue and may make it easier for your doctor to determine the best position of the catheter, thereby simplifying or shortening the procedure. It is considered investigational which means it is not approved by the United States Food and Drug Administration (FDA). This study is currently in follow-up only and is not enrolling new patients.

PREVENT VT - Prophylactic Cervicothoracic Sympathectomy for Prevention of Ventricular Tachycardia

The purpose of this study to evaluate an additional therapy option for recurrent ventricular tachycardia (VT) called cervicothoracic sympathectomy (CTS). Research has shown that a group of nerves called a ganglia feeding the lower chambers of the heart (ventricles) help start and maintain VT. A surgical procedure called CTS removes a section of these nerves. The goal of this study is to determine whether CTS can prevent VT from occurring, and therefore prevent ICD shocks.

QDOT - Evaluation of QDOT MICRO™ catheter for pulmonary vein isolation (PVI) in subjects with Paroxysmal Atrial Fibrillation (PAF)

The purpose of this study is to provide information about the safety and long-term effectiveness of the QDOT MICRO™ (QDOT) Catheter for the treatment PAF. The QDOT catheter uses RF ablation technology, to create lesions that destroy the tissue causing irregular electrical circuits. The electrodes are cooled by a flow of saline-based solution originating from small holes in the tip of the catheter electrode. The QDOT catheter uses temperature feedback measured at the tip to adjust power and irrigation flow.

About 185 patients at up to 30 centers in the US will take part in this study and participation may last up to 1 year

REDUCE LAP - A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure

This study evaluates a new device called the IASD System II, an InterAtrial Shunt Device (IASD). The device is permanently implanted in the heart. It is designed to reduce the pressure in the left atrium by creating a small opening between the left atrium and the right atrium. If it lowers the pressure in your heart at rest or during activity, it may lessen heart failure symptoms.

Up to 608 patients are expected to participate at up to 70 hospitals in the US and up to 45 outside the US.

Reveal LINQ Registry

The purpose of the Reveal LINQ Registry is to have long-term information about product performance, cost-benefit, and procedure information, and will help better understand medical care for arrhythmias (abnormal heart rhythms) for patients with the Reveal LINQ ICM. Approximately 2,300 subjects will be enrolled in the registry in the United States, Europe, Middle East and Africa, China and Japan.

This study is currently in follow-up only and is not enrolling new patients.

SAMURAI - ImageReady™ MR Conditional Pacing System

The purpose of this study is to evaluate the safety, performance, and effectiveness of a pacemaker called VITALIO MRI, the lead called INGEVITY MRI, and the piece of rubber called a ‘suture sleeve’ which secures the lead to your body. It will enroll patients who are scheduled to undergo the implantation of a pacemaker and will evaluate the investigational pacemaker system which allows patients to undergo a magnetic resonance imaging (MRI) scan.

These devices are investigational, which means they are not approved by the United States Food and Drug Administration.

This study is currently in follow-up only and is not enrolling new patients.

St. Jude AMULET - Amplatzer Amulet Left Atrial Appendage Occluder Randomized Controlled Trial

This study is for patients that have nonvalvular atrial fibrillation (AF) and are scheduled to receive a Boston Scientific WATCHMAN LAA occluder device. It is evaluating the AMPLATZER™ Amulet™Left Atrial Appendage Occluder device (AMULET). Like the WATCHMAN device, the AMULET device is designed to reduce the risk of a blood clot from the left atrial appendage (LAA). This purpose of this prospective, randomized, multicenter, active control worldwide trial is to find out if the AMULET device is safe and effective when compared to the WATCHMAN.

This study is currently in follow-up only and is not enrolling new patients.

STELLAR - Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

This study evaluates an investigational device, the Multi-Electrode Radiofrequency (RF) Balloon catheter system (used with the Multi-Electrode Circular Diagnostic catheter, Multi-Electrode RF Generator, CARTO® software, and irrigation pump) for the treatment of subjects with paroxysmal atrial fibrillation (PAF). The Multi-channel RF Generator and irrigation pump are approved in Europe.

Up to 640 people in up to 40 clinical sites in the US and outside the US will take part in this study.

TactiCath - Multi-Center Acute Safety Trial of TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the Treatment of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation

The purpose of this research study is to collect information on the safety and ablation procedure success of the TactiCath SE ablation catheter. It will evaluate the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) manufactured by Abbott. The study will enroll patients who are scheduled to undergo an Atrial Fibrillation (AF) ablation procedure. The TactiCath SE catheter is considered investigational in the United States; however, the TactiCath SE catheter has been commercially available in the European Union since May 2017.

This study is currently in follow-up only and is not enrolling new patients.

Tacticath PAS - Tacticath Contact Force Ablation Catheter Study for Atrial Fibrillation

The purpose of this post-approval research study is to collect additional data about the safety and effectiveness of the St. Jude TactiCath Quartz® Set (TactiCath Quartz® Catheter and TactiSys Quartz® Ablation System) when used to treat AF. The set, which consists of an ablation catheter and energy generator, is approved by the United States Food and Drug Administration (FDA). There are no investigational devices used in this study. This study is currently in follow-up only and is not enrolling new patients.

TactiSense - Multi-Center Acute Safety Trial of TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the Treatment of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation

This randomized study will evaluate the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) manufactured by Abbott. This radiofrequency ablation catheter is an updated version of a catheter previously approved by the Food and Drug Administration (FDA). The purpose of this research study is to collect information on the safety and ablation procedure success of the TactiCath SE ablation catheter.

This study is currently in follow-up only and is not enrolling new patients.

TANTRA II - PVAI Plus Scar Homogenization and Ablation of Non-PV Triggers Ensure Long-Term Recurrence-Free Survival in Non-Paroxysmal Atrial Fibrillation (AF)

The purpose of this study is to evaluate the effect of scar ablation (homogenization) and non-pulmonary vein (PV) trigger ablation on the success rate of the ablation procedure. Abnormal heart rhythms can be triggered from sites other than pulmonary veins (the most common sites of origin for AF). These are termed as non-PV triggers. The purpose of this study is to evaluate the effect of scar ablation (homogenization) and non-PV trigger ablation on the success rate of the ablation procedure. There are three different ablation strategies for this study. These include: (1) Pulmonary vein isolation (PVI) plus isolation of left atrial posterior wall (PWI), (2) PVI+ scar homogenization, and 3) PVI + PWI + ablation of non-PV triggers. The study will enroll 186 patients in the Austin area and participation will last 3 years.

VISITAG - Evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with the THERMOCOOL SMARTTOUCH® SF and the THERMOCOOL SMARTTOUCH® Catheters for Pulmonary Vein Isolation (PVI)

The purpose of this study is to evaluate the safety and effectiveness of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with a THERMOCOOL SMARTTOUCH® SF (STSF) and THERMOCOOL SMARTTOUCH® (ST) catheter. The VISITAG SURPONT system has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of PAF when used with THERMOCOOL STSF and THERMOCOOL ST catheters.

Participation will last approximately 12 months with up to 330 participants at up to 45 centers in the US.

Watchman CAP2 - Continued access to Watchman PREVAIL

The study will enroll patients who have a heart condition in which the upper chambers of the heart beat too fast. This condition, known as atrial fibrillation (AFib), can cause blood clots to form in an area of your heart called the left atrial appendage (LAA). It is believed that if the LAA pouch in the heart is closed, then blood clots might not be able to form in that area. This research study will evaluate an investigational device called the WATCHMAN®. The WATCHMAN® device is a round filter designed to exclude or block off the LAA (pouch) and prevent the release of blood clots into the circulatory (blood) system. This device is designed to be permanently implanted in the LAA (pouch) of the heart to prevent stroke without the need for long-term anti-coagulation blood thinners such as warfarin (Coumadin®).

This study is currently in follow-up only and is not enrolling new patients.

Watchman FLX2 - Protection against Embolism for non-valvular AF Patients: Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology

The primary objective of this study is to establish the safety and effectiveness of the WATCHMAN FLX™ LAAC Device in patients with non-valvular atrial fibrillation who require treatment for potential blood clot (thrombus) formation in the LAA. The WATCHMAN FLX™ LAAC Device is intended to prevent clots that originate from the LAA from dislodging and leading to potential stroke. These devices also potentially allow patients to stop taking their blood thinner, also known as anticoagulant. This device is investigational, which means it has not been approved by the FDA and is being evaluated in this study to compare safety and efficacy to the FDA approved Watchman device.

This study is currently in follow-up only and is not enrolling new patients.

WAVECREST - WaveCrest vs. Watchman Transseptal LAA Closure to Reduce AF-Mediate Stroke 2

This randomized study will enroll patients who have nonvalvular atrial fibrillation (AF) and are scheduled to receive an LAA occluder device. AF increases the risk for blood clots forming in the LAA due to slower blood flow. The LAA is a small pouch on the left upper chamber of your heart called the left atrium. Blood clots in the left side of the heart may go to the brain and cause a stroke. Closing the LAA might prevent blood clots from forming and escaping the LAA.

The purpose of this study is to evaluate the safety and effectiveness of the Coherex WaveCrest® Left Atrial Appendage (LAA) Occlusion System (“WaveCrest device”) by comparing it to a similar device, the Watchman device. The WaveCrest device is investigational, which means it is not approved by the FDA for commercial use in the United States.

ZODIAC - Pulmonary Vein reconnection after Pulmonary Vein Antrum Isolation at different power settings using adenosine provocation

This is a prospective, randomized, multi-center study is designed to find the optimal ablation energy strategy, and compare the rate of atrial fibrillation (AF) recurrence following ablation of the pulmonary veins (PVs) and posterior wall. The ablation is performed at different energy settings, 30 watts versus 40 watts.

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