Summaries of recent Texas Cardiac Arrhythmia Institute research studies are listed below.

AATAC-AF - Ablation vs. Amiodarone for Treatment of Atrial Fibrillation in Patients with Congestive Heart Failure and an Implanted ICD/CRTD

The purpose of this prospective, randomized trial is to determine if catheter-based atrial fibrillation (AF) ablation is superior to Amiodarone treatment for symptomatic persistent/permanent AF in ICD / CRTD patients with an impaired left ventricular function. Success will be defined by recurrence of AF, quality of life, 6-minute walk distance, heart pump function, and total number of hospitalizations.

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.

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.

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.

CABANA - Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial

This randomized clinical trial is designed to evaluate whether radio frequency AFib ablation is superior to either rate control or rhythm control drugs for reducing total mortality (primary endpoint) and decreasing the composite endpoint of total mortality, disabling stroke, serious bleeding, and cardiac arrest (secondary endpoint).

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.

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.

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.

GENEVA - Function and Mechanism of Genetic Variants Associated with 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. Earlier studies have identified certain genetic variations that are associated with AF. Your doctor is interested in assessing whether these genetic variants play a role in determining the outcome of AF ablation. This study involves evaluating a blood sample to identify certain genetic variations.

Milestone - Efficacy and Safety of Intranasal MSP-2017 for the Conversion of Induced SVT to Sinus Rhythm

This study is being done to collect data that may determine whether the study drug, an investigational intranasal drug known as MSP-2017, is able to end an episode of Paroxysmal Supraventricular Tachycardia (PSVT). This data will be collected before and while you are in the electrophysiology (EP) lab, before your doctor does your catheter ablation procedure.

NAVIGATE - 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), an 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 LV lead, CRT-D and programmer software are investigational, which means they are not 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.

PREVENT VT - Prophylactic Cervicothoracic Sympathectomy for Prevention of Ventricular Tachycardia

The purpose of this research study is to evaluate the safety and effectiveness of the LV lead (ACUITY TM X4), an RV lead (RELIANCE TM 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 LV lead, CRT-D and programmer software are investigational, which means they are not 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.

RECHARGE - Accurate Detection of Changes in Hemodynamic Markers Using Admittance Method

This study is testing a new investigational device called the CardioVol Admittance Method System. The researchers hope to learn if the new device can accurately measure LV volumes and LV Wall Motion (LVWM) in patients who already have an implanted Cardiac Resynchronization Therapy (CRT) device. The device uses the existing leads already in the heart.

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.

RIO II - Medtronic Reveal LINQ In-Office 2

RIO 2 is a two arm, randomized, prospective, un-blinded, multicenter, non-significant risk study. The primary purpose of the RIO 2 study is to demonstrate that the Reveal LINQ™ procedure performed in the in-office setting is as safe as LINQ™ insertions performed in the traditional hospital setting (operating room, cardiac catheterization or electrophysiology (EP) laboratory).

SMART SF - Safety Assessment of the Thermocool SmartTouch SF Family of Contact Force Sensing Catheters

The purpose of this non-randomized study is to provide information about the short term safety of the THERMOCOOL® SMARTTOUCH® SF Family of Contact Force Sensing Catheters. The THERMOCOOL® SMARTTOUCH® SF Family of Contact Force Sensing Catheters consists of investigational devices that have not been approved by the FDA for the treatment of PAF.

STAR-VT - Substrate Targeted Ablation Using the CoolFlex™ Irrigated Catheter Ablation System for the Reduction of Ventricular Tachycardia

The purpose of this study is to determine if Ventricular Tachycardia (VT) ablation is more effective than medication alone for the treatment of VT or prevent VT from developing in patients with an implantable cardioverter defibrillator (ICD) or Cardiac Re-synchronization Therapy Defibrillator (CRT-D). The study will also evaluate the safety and effectiveness of the Cool Flex™ Irrigated Ablation System.

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.

TARGET - Outcome of Atrial Fibrillation Termination during Ablation Without Additional Empiric Ablation

Ablation uses focused electrical energy to burn or ‘ablate’ portions of the tissue inside of the heart, creating scar tissue to stop the AF and restore a normal heart rhythm. Abnormal heart rhythms can be triggered from sites in the heart other than pulmonary veins (the most common site of origin for AF). These are termed as non-PV triggers. Additionally, complex fractionated atrial electrograms (CFAEs), sometimes recorded during AF are thought to represent sensitive areas in the heart that are necessary for maintenance of AF.

The purpose of this study is to evaluate the effect of additional non-PV trigger ablation on the success rate of the ablation in patients who converted to sinus rhythm during procedure. There are two different ablation strategies for this study. These include: (1) standard ablation until AF converts to sinus rhythm, and (2) standard ablation plus ablation of the CFAEs and non-PV triggers.

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).

VISTA - Comparison of the Effect of Ablation of the Clinically Presenting Ventricular Tachycardia (VT) Only Versus the Addition of Substrate Ablation Basedon Scar Mapping; on the Long-term Success Rate of VT Ablation

This multicenter, prospective, clinical trial is designed to assess whether a combined technique of substrate ablation and ablation of the clinically presenting VT at the site of early activation is superior to ablation of the clinically presenting VT alone, in enhancing long-term success of VT ablation.

It is hypothesized that successful ablation of clinically significant VT combined with substrate ablation based on scar mapping is more effective than ablation of the clinical VT alone, in reducing recurrences of VT in post-MI patients.

Patients will randomize patients 1:1 to:
a) Control Arm – ablation of the clinically presenting VT at the site of early activation only, or
b) Study Arm – ablation of clinically presenting VT plus substrate ablation based on scar mapping.

Patients will be followed for a maximum of twelve months to determine the recurrence of VT The sample size will be 120 patients; 60 per group.

ZERO - Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

This study is a prospective, 1:1 randomized, single-blinded, multi-center, controlled global investigation to determine non-inferiority of Blazer Open-Irrigated catheters when compared to Navistar Thermocool. This study is designed to determine if the Blazer Open-Irrigated catheters perform as well as the FDA approved Biosense Webster Thermocool catheters and CARTOimaging system.

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.