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.
AWARE
This pilot study aims to assess the impact of anxiety on the cardiac substrate remodeling in female patients with paroxysmal and persistent atrial fibrillation (AF).
Prior studies have documented strong association between anxiety and inflammation. Chronic inflammation results in structural remodeling of the atrial architecture such as fibrotic changes that supports genesis and perpetuation of AF. Besides, anxiety affects how patients perceive their illness, particularly for women, and influence healthcare utilization and economic burden. Therefore, if the role of anxiety would be ascertained, timely intervention of the same would lead to improvement in the success rate of the ablation therapy in females that highly dominate this subset of AF population.
Female patients with paroxysmal and persistent AF undergoing their first catheter ablation are eligible for the study. Consenting patients undertake 3 self-administered surveys at baseline and 12-months of follow-up. Additionally, 3D voltage mapping is performed during the ablation procedure to identify scars in the left atrium.
This study may provide information about the impact of anxiety on cardiac substrate modifications and the risk of having scar and non-PV triggers which are strong predictors of ablation failure. Therefore, future patients may benefit from strategic management of anxiety disorders along with that of AF.
This study is currently enrolling patients.
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.
Half-Normal Saline Study (AF)
The purpose of this randomized trial is to collect the procedural and outcome data on the use of half normal saline as an alternative to normal saline as an irrigant for open irrigated ablation catheters used during AF ablation.
Post-ablation AF recurrences are mostly due to non-durable ablation lesions, leading to reconnection of previously isolated pulmonary veins (PVs) and other targeted sites. More recently, it has been hypothesized that the ionic concentration of the irrigation fluid used by open-irrigated catheters can influence the lesion formation. Prior studies have reported that using half-normal saline (HNS) instead of normal saline (NS) as an irrigant for open-irrigated ablation catheters produces larger and deeper ablation lesions.
Patients undergoing first-time catheter ablation for AF are eligible for this study. After obtaining informed consent, enrolled patients are randomly assigned in a 1:1 fashion to either of the following 2 groups: 1) AF ablation using HNS as irrigant 2) AF ablation using NS as irrigant. After the ablation, patients are monitored for adverse events for the remainder of the hospitalization; moreover, per institutional protocol, the morning after the procedure they undergo a repeat blood test, which includes serum sodium concentration. AF recurrences are monitored for 1 year in the study participants.
This study is currently enrolling.
Half-Normal Saline Study (VT)
The purpose of this research study is to collect the procedural and outcome data on the use of half normal saline as an alternative to normal saline as an irrigant for open irrigated ablation catheters used during VA ablation.
In recent studies, using half-normal saline (HNS) instead of normal saline (NS) as an irrigant for open-irrigated ablation catheters was reported to produce larger and deeper ablation lesions. Certain types of ventricular arrhythmia (VA) originate deep in the myocardium, thus requiring prolonged ablation from multiple surrounding sites to completely eliminate the target VAs. In such cases, the depth and extension of the ablation lesion are crucial factors in determining the success rate of the VA ablation.
Patients undergoing first-time catheter ablation for VA are eligible for this study. A 24-hour ECG monitoring is performed in all enrolled patients to determine the PVC burden. After the ablation, patients are monitored for adverse events for the remainder of the hospitalization; moreover, per institutional protocol, the morning after the procedure they undergo a repeat blood test, which includes serum sodium concentration. VA recurrences are monitored for 1 year in the study participants.
This study is currently recruiting.
HERITAGE
The specific aim of this study is to identify the genes that cause heritable arrhythmia conditions. It is a multi-center study with the Harvard Medical School as the lead investigator. We propose to identify individuals with heritable forms of Wolff-Parkinson-White syndrome, Supraventricular tachycardia, Brugada syndrome, Idiopathic ventricular tachycardia and ventricular fibrillation, Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy, Long QT Syndrome and hypertrophic, dilated, and restrictive cardiomyopathy.
A one-time 10ml of peripheral blood sample is obtained from each subject for genetic analyses. At the end of the study, genetic analysis and long term blood sample storage will occur at the Broad Institute, Harvard Medical School, Boston, MA. The de-identified health information will be stored in a study specific, password protected RedCAP database. RedCAP database analysis will be used to study the epidemiology and clinical outcomes of inherited genetic arrhythmias.
The study is currently recruiting patients.
LIFE-STYLE study
This prospective randomized study aims to evaluate the impact of aggressive life style modification with regards to calorie-controlled diet and supervised exercise on outcome of catheter ablation in overweight and obese patients with atrial fibrillation.
Prior studies have demonstrated a direct correlation between progressive obesity and changes in atrial substrates that lead to spontaneous and more persistent AF. Moreover, reduction in BMI of >3.5 units has been reported to be accompanied by improvement in other risk factors of AF and reduction in symptom burden. Additionally, the role of autonomic neural imbalance in arrhythmogenesis is widely recognized and weight-loss and aerobic exercise are believed to reverse the autonomic remodeling and thereby enhance the electrical stability of the heart.
In this randomized trial, patients with BMI ≥26-40 undergoing their first catheter ablation are assigned to 1) intervention group (calorie-controlled diet and supervised exercise for weight-reduction and management) and 2) no-intervention group (general life-style advice). Patients enrolling in the intervention group receive free individual counseling sessions with from certified nutritionists. Moreover, local patients receive free supervised exercise training at our cardiac rehab facility. Patients that are unable to attend the cardiac rehab will perform moderate-intensity exercise such as brisk walking, jogging, cycling on their own or exercising at any fitness center for at least 150 minutes/ week.
Strict diet and exercise intervention will continue for 1 year in the intervention group. Control group patients receive general healthy life-style advices at the time of discharge following the ablation procedure. Patients will be monitored for arrhythmia recurrence for 1 year.
The study is currently recruiting.
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.
TANTRA
This multi-center randomized trial seeks to compare the efficacy of three ablation strategies: (i) pulmonary vein antrum isolation (PVAI) + isolation of posterior wall, (ii) PVAI plus scar homogenization, (iii) PVAI plus isolation of posterior wall plus ablation of non-PV triggers in persistent (PerAF) and long-standing persistent AF (LSPAF) patients. Moreover, we assess the change in quality of life using several questionnaires at baseline and 1 year.
Patients undergoing their first procedure are eligible for this study. All patients are followed up for arrhythmia recurrence for 3 years after the index ablation procedure.
The study is currently recruiting.
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
In this prospective randomized study, we aim to compare the rate of PV reconnection following PVAI performed at different energy settings (30W vs 40W) where dormant PV conduction will be unmasked by adenosine or isoproterenol (iso)-provocation.
Patients presenting with nonvalvular paroxysmal AF or Persistent AF undergoing first ablation are eligible for this study. Consenting patients are randomly assigned to either of the two groups after enrollment; Group 1: AF ablation using energy up to 30 watts, Group 2: AF ablation using energy up to 40 watts. After PV isolation is achieved, all undergo an adenosine or isoproterenol challenge test with 24 mg of adenosine (the dose of isoproterenol will be based on operator’s discretion) to check for PV reconnection. Upon identification, additional RF energy is administered to ablate the sites revealed by adenosine-provocation or isoproterenol challenge. All patients are followed up for 1 year for arrhythmia recurrence.
The study is currently enrolling patients.