Research Studies

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

  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.
  

• ASSIST – Atrial Tachyarrhythmia Suppression Strategy in ICD Subjects Trial

  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”.

• CONNECT - Clinical evaluation Of remote Notification to rEduCe Time to Clinical Decision - Medtronic

  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
  

• FIX-HF-5 – Evaluation of the Safety and Efficacy of the OPTIMIZER II System with Active Fixation Leads in Subjects with Heart Failure Resulting from Systolic Dysfunction

  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.
  
  

• FREEDOM: A Frequent Optimization Study Using the QuickOpt Method – St. Jude

  This prospective, double-blinded randomized study is designed to demonstrate that frequent AV/PV and VV delay optimization using QuickOpt in patients with a CRT-D device results in improved clinical response over standard of care (i.e. empiric programming or one time optimization using any non-IEGM optimization methods)
  
  Group 1 – Programmed to sequential BiV pacing mode with AV/PV and VV delays optimized using QuickOpt every 3 months
  Group 2 – Programmed to either simultaneous or sequential BiV pacing mode. Programmed empirically or optimized using non-IEGM method per standard of care. At Texas Cardiac Arrhythmia, this would mean using echocardiography to optimize programming.
  
  Endpoints include an Heart Failure clinical composite score, all cause – cardiovascular and heart failure mortality, and all cause – cardiovascular and heart failure hospitalizations
  

• Gen2 Cardiac Ablation System – St. Jude Medical

  A prospective, randomized, feasibility study to be conducted using a new radio-frequency (RF) catheter and generator to treat persistent atrial fibrillation feasibility study using the Gen2 Cardiac Ablation System. Randomization will occur between having the investigator use a manual power mode vs a temperature mode to create the RF lesions. The objective is to demonstrate the initial safety and initial acute efficacy of the Gen2 Cardiac Ablation System in order to determine if a pivotal trial is warranted.

• Geneheart - The Genebank at Scripps Clinic Registry

  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.

• Genetic Arrhythmia Markers for Early Detection: GAME

  The GAME study is a retrospective case control study design involving a single blood draw and a 24 hour holter monitor from case subjects who have experienced a life-threatening arrhythmia (LTA) and control subjects who have no evidence of LTAs.
  
  The primary objective is to determine the feasibility of utilizing genetic markers to identify individuals in need of an ICD (Implantable Cardioverter Defibrillator). Secondary objectives include identifying genes associated with SCD susceptibility, and risk factors for SCD as found in the CRF information, as well as correlating SNPs with co-morbidities in the subjects as found in the CRF information, and the parameters derived from the DR 190 Holter recording to search for association with SCD.
  

• IMPROVE HF - Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting

  This large scale, retrospective clinical data review sponsored by Medtronic, Inc. is designed as a practice assessment tool and educational tool to maximize practice compliance with established patient management guidelines for the treatment of heart disease.

• Insertion of Left Ventricular Pacing Leads utilizing Intracardiac Ultrasound & Velocity Vector Imaging (Dynamic Synchrony Imaging)

  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.

• Model 4396 LV Lead Study

  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.

• PROTECT AF – WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation

  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.

• RAAFT - First line Radiofrequency Ablation vs. Antiarrhythmic Drugs for Atrial Fibrillation Treatment

  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.

• RESPECT – Reducing Episodes by Septal Pacing Efficacy Confirmation Trial

  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.

• REVERSE – Re-synchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction

  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.

• SMART-AV - SMARTDELAY determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy

  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.

• ST Segment Detection Study – Medtronic

  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