Texas Cardiac Arrhythmia

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.

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 aCRT Study is a prospective, multi-center, randomized, double-blinded, worldwide IDE clinical trial sponsored by Medtronic, Inc. It is designed to evaluate the safety and efficacy of the aCRT algorithm, and demonstrate non-inferiority of the aCRT algorithm.

The aCRT algorithm provides a non-echocardiography-based ambulatory optimization of AV and VV delays.

The primary objectives will evaluate Clinical Composite Scores between treatment and control groups, and cardiac performance between aCRT and echo-optimized device settings.

Following a 2:1 ratio, approximately 349 subjects will be randomized to the aCRT Treatment arm and approximately 174 subjects will be randomized to the Control group.

This randomized, double-blinded trial sponsored by Boston Scientific will evaluate the clinical superiority of two rate-adaptive sensors in patients whose heart rates no longer increase as needed during strenuous activity. A treadmill exercise test is used to evaluate these pacemaker software features.

This prospective, randomized, blinded trial sponsored by St. Jude Medical is designed to evaluate the effectiveness of a device feature called “AF suppression” in patients receiving an implantable cardioverter defibrillator (ICD). “AF Suppression” involves pacing the upper chambers of the heart in order to reduce the risk of developing AF. Patients with a history of atrial fibrillation (AFib – an arrhythmia in the upper chambers of the heart) are randomized to have AF suppression turned “ON” or “OFF”.

The purpose of this prospective. non-randomized, multi-center, post-market, global clinical trial sponsored by Medtronic, Inc. is to assess left-heart lead implant success and complication rate using the Attain Family of left-heart leads and delivery catheters. The study plans to enroll up to 2000 subjects worldwide

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 multicenter, unblinded, randomized parallel-arm clinical trial will randomize patients to either a catheter based VT ablation or a drug treatment strategy with Amiodarone. The study is designed to determine whether RF ablation is superior to amiodarone in reducing recurrent shocks in patients with CAD, prior MI and a prophylactic ICD.

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.

CONNECT is a post-market study designed to evaluate the benefits of the ConcertoTM /VirtuosoTM Remote Management System (ConexusTM + CareAlertsTM + CareLink®). Patients are randomized to be followed using remote technology or routine doctor’s office visits. Primary objectives include demonstration that the remote management system reduces the time to clinical decision for arrhythmias, cardiovascular disease progression, and system issues compared to subjects receiving only in-office care.

Additional objectives include characterizing Healthcare Utilization (hospitalizations, ER visits, office visits), Medtronic CareLink® compliance (reduced clinic burden in getting routine device interrogations), Clinic personnel satisfaction with wireless ECG (clinician user survey), Patient Well Being (anxiety, peace of mind, illness intrusiveness), Left Ventricular Capture Management (LVCM) feature (variability in the LV threshold over time), and In-office Follow-up Burden

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.

This registry involves the collection of blood samples for DNA analysis and medical history to modify and / or augment our current diagnostic ability with the goal of discovering new therapeutic interventions.

The randomized, single blind study is designed to assess the hypothesis that positioning of the LV lead guided by dynamic synchrony imaging may allow optimal lead location in the individual patient, thus reducing the overall non-responder / failure rate. Study objectives are to acquire data using dynamic synchrony imaging at multiple LV lead locations during CRT device implantation, to determine the utility of dynamic synchrony imaging in assisting final LV lead positioning at CRT implant, and to determine if VVI/ICE guided LV lead positioning will lower the CRT non-responder rate.

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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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.

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 clinical trial sponsored by Medtronic is designed to evaluate the safety and efficacy of the Model 4396 Lead used to pace the left ventricle.

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, multicenter, randomized feasibility study is designed to evaluate the safety and efficacy of the epicardial/endocardial combined procedure using the Numeris®-AF Guided Coagulation System with VisiTrax epicardially and the commercially available Biosense Webster ThermoCool® Catheter endocardially to treat drug refractory symptomatic Paroxysmal Atrial Fibrillation (AF) patients.

Patients must have failed one class I, II, III or IV anti-arrhythmia drug, experienced 3 symptomatic episodes within the past year, and have electrocardiographic documentation of at least one episode within the past year.

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 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 non‐interventional, observational registry sponsored by Boehringer Ingelheim Pharmaceuticals, Inc. is designed to understand real‐world treatment issues. No mandated medications will be prescribed and physicians will treat patients per their usual standard of care. Consecutively diagnosed patients who meet eligibility requirements will be considered for registry enrollment. Likewise, for retrospective patients, starting 2.5 years prior to site initiation and moving forward, every patient who also qualifies for study inclusion should be included in the Registry, up to the required quota. Patient follow-up lasts 6 months.

This prospective, blinded, randomized trial sponsored by Medtronic, Inc. is designed to evaluate a group of pacemaker features called intervention pacing. These features are designed to reduce the frequency of abnormally fast arrhythmias in the upper chambers of the heart by pacing slightly faster than the normal rate. Also, intervention pacing will attempt to prevent the atria from experiencing pauses caused by irregular beats.

Also, this study will evaluate the performance of the intervention pacing features by pacing the atria (upper chambers) on the wall that divides the upper 2 chambers of the heart. Patients are randomized to have these features turned ON or OFF. A hand held monitor called the “Patient Assistant” is also used to communicate with the pacemaker as symptoms occur.

This prospective, randomized, double-blind trial sponsored by Medtronic, Inc. is designed to determine whether Cardiac Resynchronization Therapy (CRT) will result in a stabilization or improvement in patient clinical status as compared to optimal medical therapy (medications) alone in patients with asymptomatic or mild heart failure and an electrical conduction delay. CRT involves pacing both lower chambers of the heart to ‘synchronize’ the pumping action of the heart.

This randomized, double-blinded trial sponsored by Boston Scientific will investigate the effects of optimizing AV delay timing in heart failure patients receiving a Cardiac Resynchronization Therapy Defibrillator (CRT-D). The study will compare chronic changes in structural, biochemical and functional outcomes in CRT-D patients randomized to AV delay set as fixed, set with SmartDelay or determined by echocardiography.

The study is the first ambulatory evaluation of the ST Detection algorithm in the target patient population of 200 patients. Intra-cardiac electrograms and heart sounds will be collected by uploading an investigational algorithm into a Virtuoso® ICD. This multi-center, non-randomized feasibility study will evaluate the performance of the algorithm during a 6 month FU period. The primary objective is to collect ambulatory ST segment changes associated with spontaneous coronary events and exercise-induced cardiac ischemia in an ICD-indicated coronary artery disease (CAD) population.

Additional objectives include characterization of the rate of occurrence of spontaneous coronary events and all other cardiac events in ICD-indicated coronary artery disease subject population at risk for ischemia, and the EGM-based ST segment changes measured during spontaneous coronary events and exercise-induced ischemia and compare them to ST segment changes measured by the 12-lead ECG, as well as development of an EGM database of ambulatory signals, including signals captured during spontaneous coronary events and exercise-induced cardiac ischemia, and evaluation of the ability of the device’s Patient Alert microphone to record heart sounds in a subset of subjects

Hypothesis: Persistent or long-standing persistent AF, resistant to anti-arrhythmic drugs (AADs), can be treated with surgical Maze procedure or catheter-based pulmonary vein isolation. The aim of this study is to compare the safety and effectiveness of the two procedures.

This prospective randomized study will compare the efficacy and safety of radio-frequency AFib ablation with or without linear lesions by a minimally invasive surgical procedure versus catheter based ablation techniques in patients with persistent or long standing persistent atrial fibrillation.

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.