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.

AXAFA - Anticoagulation using direct factor Xa inhibitor apixaban during AF ablation

This is a randomized, outcome assessment, multi-center trial comparing apixaban to vitamin K antagonist (VKA) therapy to determine the optimal anticoagulation therapy for patients undergoing catheter ablation of atrial fibrillation.

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.

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.

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.

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.

DECAF II - Determining the association of chromosomal variants with non-PV triggers and ablation-outcome in AF

Atrial Fibrillation (AF) often occurs with heart disease. However, not all individuals with the same heart abnormalities suffer from AF. Similarly, catheter ablation successfully treats AF in some people, but in others AF recurs after ablation. These observations indicate a possible genetic predisposition that could determine whether an individual is prone to develop AF or not, as well as the outcome of an ablation procedure.

This prospective pilot study will examine the association of specific genetic variants (single nucleotide polymorphisms) located on chromosome 1, 4 and 16, with presence of NPVT, as well as ablation outcome in AF patients.

Dobutamine versus isoproterenol for inducibility of atrial arrhythmias in atrial fibrillation ablation

During an atrial fibrillation (AF) ablation procedure, a medication called isoproterenol is used to stimulate atrial arrhythmias (abnormal rhythms in the upper chambers of the heart) and identify potential targets for ablation. This study is being conducted to evaluate an alternative medication called dobutamine. Both isoproterenol and dobutamine increase the strength and rate of the heart’s pumping action. Sometimes isoproterenol can lower blood pressure by relaxing blood vessels. Dobutamine does not have this effect. Otherwise, the medications are similar.

The purpose of this research study is to collect data on the use of dobutamine as an alternative to isoproterenol to cause atrial arrhythmias during AF ablation

EpiEP EpiAccess

The purpose of this registry is to collect long term information to confirm the safety and effectiveness of using a new type of pericardial access device (whose name is EpiAccess). The EpiAccess System is a specialized system that assists your doctor in understanding when they are in this anatomical location around your heart. “Pericardial Access” is a term which defines access to the sac around your heart which allows the physician to place the catheters to perform catheter ablation.

The EpiAccess device has been approved by the United States Food and Drug Administration (FDA) for use in participants.

ERAF - Immediate vs. Deferred Cardioversion Strategy for Early Recurrence of Atrial Fibrillation after Ablation

This study will evaluate post-op Atrial Fibrillation (AF) ablation patients who experience recurrence of AF within 90 days of their ablation procedure. It aims to determine if keeping the heart in a normal rhythm during those first three months improves long term success of the ablation procedure. Patients with a diagnosis of early recurrence AF (ERAF) will be prospectively randomized to immediate versus deferred cardioversion to determine if keeping the heart in a normal rhythm during those first three months improves long term success 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.

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 Reveal LINQ Registry

The purpose of the Reveal LINQ Registry is to collect long-term information about product performance, cost benefit, procedure information, and will help better understand medical care for arrhythmias (abnormal heart rhythms) for patients with the Reveal LINQ Insertable Cardiac Monitor (ICM).

Approximately 2,300 subjects will be enrolled in the registry in the United States, Europe, Middle East and Africa, China and Japan. You will be followed for three years from insertion of your Reveal LINQ ICM.

OAT - Safety of Oral Anticoagulation Therapy withdrawal after successful Pulmonary Vein Antrum Isolation in Patients with Atrial Fib and Associated High Risk Factors for Embolic Events

Patients who have undergone successful PVAI for symptomatic high-burden paroxysmal AF refractory to antiarrhythmic drug (AAD) therapy will be randomized (1:1) to one of two study arms: (1) OAT Withdrawal (Test) Group or (2) OAT (Control) Group. Hypothesis: High risk subjects who have successful PV antrum isolation and remain free from AF recurrence for 9-21 months post ablation procedure can discontinue their OAT without an increased risk of thromboembolic events as compared to those who remain on OAT.

PARACHUTE IV - Percutaneous Ventricular Restoration in Chronic Heart Failure due to Ischemic Heart Disease

This multicenter, randomized study will evaluate the safety and effectiveness of an investigational device, called the Parachute device, in the treatment of patients with severe heart failure due to a heart attack. The Parachute is a small membrane implanted into the left ventricle (left lower chamber) of your heart, and is intended to isolate the malfunctioning portion of the ventricle.

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).

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.

reMARQable - nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation

The current ablation catheters ablate one point at a time. Your doctor applies multiple single ablations (called lesions) in an attempt to make a line of lesions. New catheters called nMARQ™ have been designed to create long continuous linear lesions in one application. The purpose of this randomized, multi-center study is to test the safety and effectiveness of the investigational nMARQ™ catheter system when used to treat Atrial Fibrillation.

RESCUE - Renal Sympathetic Denervation to Suppress Tachyarrhythmias in ICD Recipients

In this current multicenter trial, called RESCUE, persons who are receiving an ICD will be randomly assigned (like the flip of a coin) to either the denervation procedure or nothing further.

Recently, there is a new procedure called renal sympathetic denervation (RSDN) that is being used in patients with high blood pressure, but may also help prevent ICD shocks in patients like you. This procedure involves placing a catheter within the arteries that supply blood to the kidneys and cauterizing (applying heat) to the wall of the vessel. This affects nerves that travel in the walls of these arteries and send information back and forth from the kidney and brain. Studies have shown that using heat to deactivate these nerves decreases the activity of the sympathetic nervous system (the nerves that control the release of adrenaline-like hormones in the body). We believe that by doing this denervation procedure, we may be able to decrease the need for the ICD to shock you. In the ideal situation, the denervation procedure will largely prevent the abnormal heart beats, and the ICD will simply be there as back-up therapy.

Siemens P6 - Assessment of the utility of the Siemens P6 volume ICE catheter in electrophysiology and structural heart disease procedures

This study is for patients that are scheduled to undergo Atrial Fibrillation (AF) ablation, Ventricular Tachycardia (VT) ablation, or implantation of a Left Atrial Appendage LAA) occluder. During these procedures, the doctor uses an ultrasound catheter inside the heart to maintain images of the heart throughout the procedure. This is known as an intracardiac echocardiogram (ICE). The P6 ICE catheter that will be evaluated in this study offers a larger field of view. The purpose of this research study is to better understand the role and impact of the Siemens volume ICE P6 catheter technology in AF and VT ablation procedures and LAA procedures.

Vein of Marshall Ethanol Infusion for Persistent Atrial Fibrillation

Ablation uses focused electrical energy known as radiofrequency (RF) energy to burn or ‘ablate’ portions of the tissue inside of the heart to stop the AF and restore a normal heart rhythm. In addition to using RF, our doctors are evaluating the use of alcohol injected into a
vein in your heart called the Vein of Marshall (VOM) in addition to your standard catheter ablation procedure.

The purpose of this research study is to determine if a standard ablation procedure combined with alcohol infusion in the Vein of Marshall is more successful than a standard ablation alone. The use of alcohol for AF ablation is investigational, which means it is not approved by the United States Food and Drug Administration (FDA).

Meet Our Physicians

Meet Our Physicians

Learn About Heart Rhythm Disorders

Learn About Heart Rhythm Disorders

Review Our Procedures

Review Our Procedures

Meet Dr. Andrea Natale

Meet Dr. Andrea Natale

Our Latest News

Our Latest News