Texas Cardiac Arrhythmia

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.

The primary purpose of this registry sponsored by Boston Scientific is to evaluate and report on the long-term reliability and clinical performance of the ACUITY Spiral Lead. The objective is to evaluate the complication-free rate of the lead to verify long-term performance. Patients must have an analogue telephone line which is required to communicate with a device management system.

This multicenter, double-blind, randomized, clinical trial will assess the impact of 75 mg azimilide vs placebo on occurrence of cardiovascular hospitalizations, cardiovascular emergency room visits, or death in patients with an implantable cardioverter defibrillator.

This multicenter, prospective, clinical trial will randomize patients 1:1 to:

1) Control Arm – Conventional approach which includes pulmonary vein isolation (PVI) and ablation of extra-pulmonary trigger, or

2) Study Arm – LAA isolation along with the conventional ablation strategy

Hypothesis: LAA isolation combined with standard ablation procedure enhances the procedural success rate of chronic atrial fibrillation ablation.

This is a prospective, multicenter, non-randomized clinical evaluation is to demonstrate the safety and effectiveness of the THERMOCOOL® SMARTTOUCH™ Catheter family with Contact Force Sensing Capability in the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (AF) during standard electrophysiology mapping and RF ablation procedures.

This prospective, multi-center, randomized clinical trial sponsored by Boston Scientific is designed to evaluate the safety and efficacy of the Blazer® Open-Irrigated RF ablation catheter. Patient are randomized 1:1 to the Blazer® vs FDA approved irrigation catheter.

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).

This prospective, randomized, unblinded study is designed to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System in the treatment of symptomatic atrial fibrillation by creating electrical isolation of the pulmonary veins.

Patients must have failed one class I, II or III anti-arrhythmia drug, experienced two symptomatic episodes within the past 6 months, and have electrocardiographic documentation of at least one episode within the past year.

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.

COMPARE is a multicenter, open label, prospective, randomized clinical trial designed to assess whether continuous Coumadin therapy during radio-frequency catheter ablation of patients with atrial fibrillation, reduces the incidence of peri-procedural TE in high-risk patients.

It is hypothesized that continuous Coumadin therapy is more effective than the interrupted strategy in preventing peri-procedural thromboembolic events.

Patients are randomized to either continuous or interrupted Coumadin therapy during the procedure. Sample size is 1560 patients; 780 patients per group

The intent of this study sponsored by St. Jude Medical is to evaluate signal quality and the quality of the recordings of the SJM Confirm device as compared to a surface ECG in patients who have experienced unexplained symptoms such as dizziness, palpitations, chest pain, syncope, shortness of breath, are at risk for cardiac arrhythmias, or patients who have been previously diagnosed with atrial fibrillation, or who are susceptible to developing atrial fibrillation. Safety data on the SJM Confirm device will also be collected.

This prospective, nonrandomized, unblinded pilot study will explore the effect of catheter ablation on migraine headache in patients with and without a history of migraines.

Migraine status of all the enrolling patients will be surveyed pre-procedure using a migraine questionnaire, and a follow-up migraine survey will be completed at 3 months post-procedure. MRI imaging and neurological exams will be performed prior to the ablation procedure and within 24 hrs post-procedure.

This study is a randomized, prospective, double-blind, multi-center study enrolling heart failure patients who require an ICD and do not have delayed electrical conduction in the lower chamber. The random assignment is to one of the two study groups (CRT=ON, CRT=OFF). The primary objective is to demonstrate whether Cardiac Resynchronization Therapy (CRT=ON) in heart failure subjects with narrow QRS and echocardiographic evidence of ventricular dyssynchrony will significantly reduce the combined endpoint of all-cause mortality or first hospitalization for worsening heart failure (HF)

This prospective, randomized, single blind, multicenter, interventional study sponsored by Endosense is designed to evaluate the safety and effectiveness of the TactiCath® Set for symptomatic paroxysmal atrial fibrillation. Patients are randomized 1:1 to receive treatment with either the TactiCath® Set or an FDA approved ablation catheter This study aims to demonstrate non-inferiority of the study device to the control device.

This randomized, double-blind study sponsored by Impulse Dynamics, Inc. is being conducted to evaluate the safety and efficacy of a pacemaker-like device designed to treat heart failure by stimulating the intraventricular septum (wall between the lower chambers of the heart). Cardiac contractility modulation (CCM) stimulates the heart between normal heartbeats. This technology is evaluated in heart failure patients with are receiving optimal heart failure medications, and are not candidates for bi-ventricular pacing (CRT). The Control group remains optimized on heart failure medication.

The Hansen Sensei Robotic Catheter System with the Artisan Guide Catheter is intended for introducing and positioning the ThermoCool Diagnostic/Ablation Catheter in patients with atrial fibrillation.

Study Design: Prospective, multi-center, randomized study comparing Hansen remote vs. manual introduction and positioning of the Biosense ThermoCool catheter for mapping and ablation in patients with atrial fibrillation. Study subjects will be randomized at a 2:1 ratio between the remote and manual guide catheter groups.

Study Objective: To demonstrate the safety and chronic procedural success rates for the Biosense ThermoCool catheter remotely introduced and positioned through the Artisan Guide Catheter to manual introduction and positioning of the ThermoCool within the Agilis guide catheter.

This randomized, double-blind study is designed 1) to assess the efficacy of oral prednisone in improving the outcomes of pulmonary vein isolation with radiofrequency ablation, and 2) to measure the inflammatory cytokine response to radiofrequency ablation for atrial fibrillation with or without prior prednisone treatment.

We postulate that acute swelling of the atrial wall from radiofrequency (RF) energy causes acute inflammation of the myocardium and swelling that can result in leaving large atrial tissue between the swollen RF application spots. The unablated but “shocked” tissue will remain non-conductive in acute phase mimicking complete isolation and once inflammation is subsided, resumes conduction resulting in atrial fibrillation recurrence.

Hypothesize: By reducing acute inflammation and swelling, the RF energy can be effectively and reduce the unablated tissue resulting in better outcomes.

The purpose of this study sponsored by St. Jude Medical is to test the safety and efficacy of the Therapy™ Cool Path™ Duo Irrigated Ablation System (“Cool Path Duo Cardiac Ablation System”) for the treatment of symptomatic paroxysmal atrial fibrillation. Patients are randomized to test for non-inferiority with an FDA approved open irrigated RF systems for the treatment of Paroxysmal Atrial Fibrillation (PAF), namely the Thermocool catheter.

Primary Objectives
To assess:
• the acute procedural success rate,
• the number of subjects in which freedom from symptomatic AF one year post-procedure occurs when using the Cool Path Duo Cardiac Ablation System
• the use of the system does not result in an unacceptable risk of serious adverse events (SAEs).

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This prospective, multi-center, randomized study sponsored by St. Jude Medical will evaluate the safety and clinical effectiveness of the implantable LAP Monitoring System(s) linked with a physician-directed, patient self-management therapeutic strategy to limit LAP excursions in a patients with advanced heart failure (Treatment group). Patients are randomized 1:1 to LAPTOP or the Control group which will receive optimal medical therapy.

Candidates must meet all of the following: • appropriate medical therapy for heart failure • NYHA Class III symptoms • At least 1 HF hospitalization w/in last 12 mths

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.

This prospective, multi-center, non-randomized, feasibility, study sponsored by Boston Scientific will collect chronic ambulatory data from multiple sensors available to CRT-D devices in order to develop algorithms for the early detection of worsening Heart failure.

Patients must currently have an implanted COGNIS CRT ICD (Model N119 or N120), and have at least one documented heart failure event within the previous 6 months or two in the previous 12 months.

This study is a prospective, non-randomized, single-arm, multicenter condition of approval evaluation in follow up to FDA approval. The primary objective is to provide additional, corroborative safety data for the NaviStar ThermoCool catheter for the treatment of subjects with sustained, monomorphic VT or incessant VT associated with coronary artery disease

This registry sponsored by Biosense Webster, Inc. is a prospective, multi-center, non-randomized post approval evaluation designed to provide additional corroborative short-term safety and long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters in the treatment of symptomatic PAF.

The purpose of this feasibility study is to evaluate the safety and efficacy of the epicardial / endocardial combined procedure using the nContact Numeris®-AF Guided Coagulation System with VisiTrax®epicardially and the St. Jude Medical Therapy™ Cool Path™ Ablation Catheter endocardially, to treat longstanding persistent (LSP) Atrial Fibrillation (AF) patients.

Patients must be less than 80 years of age, and have experienced AFib for no greater than 10 years.

This is a multi-center, prospective, open label, feasibility clinical study, to be conducted at up to five (5) investigational sites (USA). Twenty five (25) symptomatic longstanding persistent AF refractory or intolerant to at least one AAD (Class I through IV) subjects will be enrolled in the study for a 2 year duration.

This prospective, randomized, multi-center, feasibility study sponsored by Boston Scientific will compare data output of the Physiological Response to Activity (PRA) algorithm to the gold standard of a treadmill cardiopulmonary stress test, as well as evaluate the repeatability of the measures during activities of daily living over time.

The secondary objectives are to compare data from the heart sounds sensor with echo measurements, evaluate the repeatability of heart sounds during activities of daily living, and collect ambulatory posture information.

Patients must currently have an implanted COGNIS CRT-D model N119 or N120, and be ‘optimized’ on heart failure medications for at least 30 days.

Patients with atrial fibrillation requiring Coumadin are randomized 2:1 to the Watchman device vs. Coumadin. All patients remain on Coumadin and aspirin for at least 6 wks, then Plavix and a baby ASA until the 6 month point.

Patients must have a CHADS2 score of 2 or greater; Patients with a CHADS2 score of 1 may be included if any of the following apply:

· The patient is a female age 75 or older
· The left ventricular ejection fraction is > 30 and < 35%
· The patient is age 65-74 and has diabetes or coronary artery disease
· The patient is age 65 or greater and has documented congestive heart failure

This prospective, multicenter clinical trial aims to compare the impact of ablation of perimitral flutter only versus cardioversion and repeat isolation of PV with ablation of additional triggers, on procedure outcome. AF patients presenting for redo-ablation with PMFL will be randomized to perimitral flutter ablation only or cardioversion and re-isolation of PV plus ablation of additional triggers.

Study Hypothesis Repeat PVI (pulmonary vein isolation) and ablation of additional triggers combined with PMFL ablation in cardioverted patients provide better cure rate for patients presenting with recurrence of AF with perimitral flutter after a previous AF ablation

This prospective, randomized trial sponsored by Atritech, Inc is designed to evaluate the safety and effectiveness of the WATCHMAN device. The device occludes the left atrial appendage (pouch) in the heart and is designed to prevent stroke in patients with atrial fibrillation who are currently taking blood thinning medications to guard against stroke.

This non-randomized, multi-center study is designed to evaluate the acute and chronic performance of the St. Jude Medical QuickFlex®μ 1258T LV lead in patients indicated for implantable cardioverter defibrillator and cardiac resynchronization therapy. The study will also characterize the complication rates and device electrical performance.

This randomized clinical trial is designed to test the hypothesis that pulmonary vein isolation as the first line of therapy is superior to conventional drug therapy for the prevention of recurrence of atrial fibrillation. As a secondary objective, the trial is designed to demonstrate that catheter-based ablation for atrial fibrillation can be performed with an acceptably low risk of complications.

This randomized double-blind placebo-controlled clinical trial will enroll1,440 high-risk ICD patients who will be treated with ranolazine or placebo. The study aims to determine whether Ranolazine will decrease the likelihood of ventricular tachycardia or ventricular fibrillation (VT/VF) requiring ICD therapy or resulting in death. Follow-up will continue for 2 years.

This prospective randomized study aims to investigate the effect of continuous versus interrupted use of Amiodarone on the procedure outcome in long-standing persistent (LSP) atrial fibrillation patients undergoing pulmonary vein antral isolation (PVAI).

Hypothesis: Withdrawal of Amiodarone 5 months before procedure results in unmasking of additional focal triggers, ablation of which leads to an improved procedure outcome in LSP-AF patients.

Patients must be taking Amiodarone for at least 3 months prior to enrollment.

This multicenter randomized trial will randomize patients 2:1 to the use of the Vdrive LASSO navigation versus manual LASSO navigation. The Vdrive will facilitate fully remote procedures by allowing physicians to manipulate circular mapping catheters from a control room in conjunction with the magnetic navigation system while maintaining a safety profile that is not inferior to manual LASSO navigation.

This unrandomized feasibility study will evaluate a new software version of ATP in existing ICD patients with a history of ventricular tachycardia.

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.