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AcQMap® US Registry of Procedural and Long-term Clinical Outcomes (Discover-US)

The purpose of this registry is to collect additional data on the performance of the AcQMap System. It will enroll patients scheduled for an ablation procedure to treat a complex arrhythmia (irregular heartbeat). This registry will evaluate the AcQMap System. This new imaging and mapping system is approved by the Food and Drug Administration (FDA) and is designed to allow the doctor to “map” the exact places the impulses come from within the heart in order to better target the best places for the ablation. Use of this new diagnostic method of “mapping” will not change the other devices (such as ablation catheters) used for the ablation. 

aMAZE CAP - Left Atrial Appendage Ligation with the LARIAT+®Suture Delivery System as 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 using a newer non-surgical procedure to close the LAA combined with catheter ablation for persistent 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. 

Cardiva SDD - "CARDIVA MVP VVCS Same Day Discharge (SDD)” PostMarket Registry Protocol

This study is for patients who are scheduled to undergo an atrial fibrillation (AF) ablation procedure. At the beginning of the procedure, several puncture holes are made in the leg veins (groin area) to insert medical equipment that is needed to perform the procedure. Once the procedure is finished, these holes need to be sealed (closed) to prevent bleeding. The VVCS device is a small collagen (cotton-like) patch that is placed just outside of the vein and is intended to plug the hole and stop the bleeding. The patch is absorbed by the body (dissolves) in about three months. When the vein holes are closed with this type of device, patients may be able to get out of bed and walk sooner, and possibly be discharged on the same day. The purpose of this registry is to collect data about your procedure to help make decisions about what procedure and devices to use related to discharging patients the same day as their procedure.

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

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.

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.

CHAMPION-AF - WATCHMAN FLX vs NOAC for Embolic Protection in the Management of Patients with Non-Valvular Atrial Fibrillation

This trial will enroll patients with non-valvular atrial fibrillation (AF). AF can cause blood to pool in the area of the heart called the left atrial appendage (LAA), which can lead to an increased risk for stroke. The current standard of care to prevent stroke in patients with AF is long-term oral anticoagulation (OAC) therapy or, in appropriately selected patients, an implant of a Watchman FLX device. 

The primary objective of this randomized study is to determine if LAA closure with the Watchman FLX device is a reasonable alternative to non-vitamin K oral anticoagulants (NOACs). The Watchman FLX device has been approved by the FDA but is considered investigational for this study. 

Cryo AF Global Registry

Participants in this study are scheduled to have a cryoablation procedure using the Medtronic Arctic Front™ System and Family of Cardiac Cryoablation Catheters (Arctic Front™) for the treatment of your atrial fibrillation (AF). This type of procedure targets cardiac tissue that is causing your AF in order to freeze and destroy the abnormal tissue. The purpose of this study is to evaluate and describe clinical performance and safety data in a broad patient population treated with the Arctic Front™ System which is approved by the U.S. Food and Drug Administration (FDA).

A minimum of 1,000 subjects will be in this study at a minimum of 30 sites worldwide. Participation in the study lasts 2 years. This study is currently enrolling.

CATALYST - Clinical trial of atrial fibrillation patients comparing left atrial appendage occlusion therapy to non-vitamin K antagonist oral anticoagulants

The Amplatzer™Amulet™ Left Atrial Appendage (LAA) Occluder (Amulet) device is intended to be permanently implanted within the LAA. The LAA is a small pouch attached to the upper left chamber of your heart, the left atrium. In patients with non-valvular AF, clots can form on the LAA and travel to the brain, sometimes causing an ischemic stroke. The Amulet device is designed to seal off the LAA from blood flow, preventing clots from leaving the LAA and traveling to the brain. 

The purpose of this randomized study is to compare the safety and effectiveness of the Amulet device compared to non-vitamin K antagonist oral anticoagulants (NOACs) for ischemic stroke reduction. Patients will be randomized 50:50 to either receive the Amulet device or receive NOAC therapy.

The Amulet device is approved in some countries outside of the US but is an investigational device in the US.

 

 

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.

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

D-Dimer CLOT - Blood Coagulation Response After Percutaneous Left Atrial Appendage Occlusion

D-dimer is a protein produced when clotting occurs within the body’s blood circulation system. When the left atrial appendage (LAA) is completely sealed, a clot will form inside the LAA and produce D-dimer. This study will evaluate D-dimer levels in the blood before and after a patient has undergone an LAA occlusion procedure to determine if there are changes that could predict complete sealing of the LAA.

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.

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 CRTpatients 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.

The FARAPULSE ADVENT Trial: A Prospective Randomized Pivotal Trial of the FARAPULSE Pulsed Field Ablation System Compared with Standard of Care Ablation in Patients with Paroxysmal Atrial Fibrillation

This study will enroll patients who are scheduled to undergo an ablation to treat atrial fibrillation (AF). The purpose of this study is to evaluate the safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation System and investigate whether using the system helps to reduce the occurrence of AF. The FARAPULSE™ Pulsed Field Ablation System is a new investigational ablation system that involves the use of a catheter in the pulmonary veins connected to the heart. It delivers pulsed electric energy to create scar tissue around the openings of the veins where the misfiring first starts. The system is experimental which means it is not approved by the Food and Drug Administration (FDA) for commercial use. This clinical study is designed to collect data in the United States and compare it to other devices that are currently approved to treat AF.

GSAF - Association of Genetic Variants with Risk of Stroke in Patients with Atrial Fibrillation Off Anticoagulation

The purpose of this study is to examine the association of genetic variants with formation of a blood clot in the heart’s upper left chamber (left atrium) and stroke/TIA in patients remaining off anticoagulation therapy following a left atrial appendage isolation (LAAI) procedure. The study will enroll patients who have undergone an LAAI procedure for AF. Participation will include one blood draw and will last one day.

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.

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.

Medtronic ADAPT Response Study

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.

MARVEN - Clinical, Electrocardiographic, and Cardiac Magnetic Resonance Imaging Risk Factors Associated with Ventricular Tachyarrhythmias in Nonischemic Cardiomyopathy

This study is for patients with non-ischemic cardiomyopathy who are scheduled to receive a cardiac resynchronization therapy defibrillator (CRT-D) device, which treats rapid abnormal heart rhythms in the lower chambers of the heart. These rhythms are called ventricular tachycardia (VT) and ventricular fibrillation (VF). It is believed that using cardiac magnetic resonance (CMR) imaging may improve the detection of heart damage and identify patients at risk for VT/VF who might benefit from receiving a CRT-D device.

The purpose of this study is to determine what clinical, electrocardiographic (ECG) and CMR factors identify those at-risk patients through the collection of ECG and CMR data.

This is a multicenter study that will enroll 350 subjects.

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.

Milestone Pharmaceuticals Study of Etripamil Nasal Spray for Patients with Paroxysmal Supraventricular Tachycardia

This study is evaluating the safety of a drug called etripamil nasal spray (NS) for patients with paroxysmal supraventricular tachycardia (PSVT).  It is being conducted to help determine how safe and effective etripamil NS is when taken without medical supervision, how well it works to end an episode to PSVT, how it changes symptoms related to PSVT, and how safe and effective it is when taken for more than 1 episode of PSVT.

The drug will be self-administered at home intranasally (that is, sprayed in the nose). Up to 3000 subjects with PSVT at research sites around the world will be enrolled.

OPTIMIZER Smart Post-Approval Study

This study seeks to enroll patients who are scheduled to undergo implantation of the OPTIMIZER Smart device to treat heart failure (HF). HF is treated with medications to improve the strength of the heart muscle and reduce the amount of work the heart must do. However, medications are not always a successful treatment. The OPTIMIZER Smart delivers HF therapy called cardiac contractility modulation, or CCM therapy, to those patients who remain symptomatic despite treatment with medication.

The purpose of this post-approval study (PAS) is to evaluate the safety of long-term use of the OPTIMIZER Smart and CCM therapy. The study will also evaluate the effects of CCM therapy on your quality of life and HF symptoms. 

Option - Comparison of Anticoagulation with Left Atrial Appendage Closure after AF Ablation

The purpose of this study is to determine if LAA closure with the WATCHMAN FLX Device is a reasonable alternative to OAC following AF ablation. The WATCHMAN FLX™ LAAC Device is intended to prevent clots that originate from the LAA from dislodging and leading to potential stroke. 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. The study expects to enroll 1600 subjects at about 150 study centers around the world.

This study is currently enrolling new patients.

PERSIST-END - Safety and Effectiveness of TactiCath ™ Contact Force, Sensor Enabled ™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation

This study will enroll patients who experience symptomatic persistent atrial fibrillation (AF) and are scheduled to undergo an ablation procedure as treatment for their AF. The purpose of this study is to demonstrate that the TactiCath SE catheter is safe and effective for ablating this symptomatic persistent AF that was not effectively treated with medication.

The TactiCath SE ablation catheter is the device being tested in this study and is an updated version of a catheter previously approved by the FDA. However, the TactiCath SE catheter has not been studied to treat this type of AF.

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

Physiologic Pacing Registry - Abbott

The purpose of this prospective, observational, multi-center registry is to collect medical information and experiences from patients who are scheduled to be implanted with an Abbott device. The device leads (insulated wires) are implanted in the heart to stimulate the heart muscle. Those leads are positioned in locations to best mimic the heart’s normal electrical conduction pathways, which is known as physiologic pacing. The information and experience collected from the device and leads for the registry will help medical professionals better understand physiologic pacing.

PLEA - Posterior Wall and/or Left Atrial Appendage Empiric Electrical Isolation for Non-Paroxysmal Atrial Fibrillation

This randomized study is looking to enroll patients who are scheduled to undergo a catheter ablation to treat persistent atrial fibrillation (AF). The purpose of this study is to assess whether ablation of the posterior wall, left atrial appendage (LAA), and coronary sinus, along with standard PV ablation for AF enhances the long-term success rate of catheter ablation. 

This study will be equally randomized to four ablations groups: 1) pulmonary veins alone, 2) pulmonary veins + posterior wall, 3) pulmonary veins + posterior wall + LAA, or 4) pulmonary veins + posterior wall + LAA + coronary sinus. 

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 ICDshocks.

PURE EP 2.0 - Novel Cardiac Signal Processing System for Electrophysiology Procedures

This study is for individuals who are scheduled for an elective cardiac ablation procedure. During the ablation procedure, doctors will use equipment to acquire and display electrical signals from inside your heart. These signals provide important diagnostic information and help guide the doctor during your ablation procedure. Improving the quality of collecting and viewing a heart’s electrical signals may provide better diagnostic information for doctors and lead to more effective ablation procedures. The PURE EP™ system is an FDA-approved cardiac signal processing system with new technology that may produce better quality signals of a heart’s electrical activity. The purpose of this study is to further establish the effectiveness of the PURE EP™ system, and also to compare the PURE EP™ system cardiac signals to cardiac signals from other systems, and to determine whether the PURE EP™ signals provide additional or better diagnostic information for guiding ablation procedures. Participation in this study ends when the ablation procedure is complete.

This study is currently enrolling.

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 of paroxysmal atrial fibrillation (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. The study will enroll patients with PAF who are scheduled to undergo an ablation procedure.

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

PULSED-AF - Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF

This study will enroll patients who are scheduled to undergo an ablation procedure to treat atrial fibrillation (AF). The purpose of this study is to try to obtain data that may demonstrate the safety and effectiveness of a new ablation system that uses electricity to terminate/stop (ablate) AF rather than radiofrequency, call the Pulsed Field Ablation (PFA) system, for the treatment of AF. 

The use of this PFA system in this study is a novel form of treatment in humans and will provide first in-human insights into clinical safety and device function of the PFA system for pulmonary vein isolation and AF ablation.  For this reason, the cardiac ablation procedure will be considered experimental in this study. While some of the PFA system accessories are commercially available, all the components used will be considered investigational when used with the PFA system

RAAFT3 - First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Persistent Atrial Fibrillation Treatment

The purpose of this multi-center, randomized study is to evaluate whether ablation of atrial fibrillation (AF) is superior to antiarrhythmic drugs (AADs) as a first line of treatment in patients with persistent AF. The ablation catheter and medications used in this study have been approved by the Food and Drug Administration (FDA).

Patients will be randomly assigned into either the AAD Medication Group or the Ablation Group. For every one participant randomized into the AAD Medication Group, two will be randomized into the Ablation Group. 

RFMx - Guideline Driven Nurse Practitioner Based Integrated Digital Health Atrial Fibrillation Clinics with Remote Monitoring and Wearable Devices

This study will enroll patients who are planning to undergo or have previously undergone an Atrial Fibrillation (AF) ablation procedure. The purpose of this study is to evaluate a computer software platform, RFMx, for patients who require additional intervention with medications or ablation to control AF. The software is designed to enable a doctor or nurse to track aspects of their patients’ health due to its integration into an electronic medical record.

Patients will participate in a 12-week program targeting physical activity, food / diet, stress management / well-being, smoking cessation, medical adherence, and CPAP adherence, which is supported via coaching and tracked, through the RFMx app. 

There are no investigational medications or devices used in this study. Your participation in the study will last for 3 months, and the study will enroll 30 subjects in the Austin area.

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.

SyncAV Post-Market Trial

This study will enroll patients who are scheduled to undergo implantation of a cardiac resynchronization therapy (CRT) device to treat heart failure. The purpose of the study is to evaluate changes in the heart size between baseline and 12 months in patients with a CRT device that has been programmed with a feature called SyncAV compared to those with standard CRT device settings. Randomization will occur post-implant with an equal chance of being assigned to the SyncAV group vs the Standard CRT group. The SyncAV feature is programmed in the device and works automatically to match the CRT device pacing with the heartbeat. 

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

This study evaluates a new investigational device, the Multi-Electrode Radiofrequency (RF) Balloon catheter (HELIOSTAR) (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) who are undergoing ablation. 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.

TactiFlex SE - Safety and Effectiveness of TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex SE) for the Treatment of Drug Refractory, Symptomatic, Paroxysmal Atrial Fibrillation

This study is for patients that are scheduled to undergo Atrial Fibrillation (AF) ablation procedure. The purpose of this study is to demonstrate that the investigational TactiFlex Sensor Enabled catheter is both safe and effective. The catheter makes use of a sensor to measure the contact force being applied throughout the ablation as well as a magnetic sensor used for tracking with the Ensite Precision Mapping System. This study will enroll 355 patients at up to 40 sites worldwide. Involvement lasts approximately 12-months from the time of the ablation procedure.

This study is currently 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.

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.

Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation (Ultra-HFIB): A Pilot Study

This study will enroll patients scheduled to undergo an ablation procedure to treat Atrial Fibrillation (AF) and have high blood pressure. The purpose of this study is to examine the potential additional benefit of performing Renal Sympathetic Denervation (RSDN) at the same time as an AF ablation procedure. It seeks to determine if the procedure can decrease the recurrence of AF and help control high blood pressure, improving the long-term success of the AF ablation procedure. The use of RSDN in this study is investigational, which means it has not been approved by the United States Food and Drug Administration (FDA).

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.

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