Arrhythmia Associates LLP

Clinical Trials

Trial Name	Protect AF - Watchman device for Atrial fibrillation patients
Sponsor	Atritech, Inc
Description	The WATCHMAN device is designed to keep harmful sized blood clots from entering your blood stream, potentially causing a stroke. This is for atrial fibrillation patients who are eligible for long term Coumadin therapy and are eligible to come off Coumadin. Patients are randomized to receive the implant versus staying on Coumadin for the duration of the trial.
Further Information	www.atritech.net Sally Keyte, Inova Research Center Inova Fairfax Hospital 703-776-2995

Trial Name	OPTIMIZER — Evaluation of the Safety and Efficacy of the OPTIMIZER System with Active Fixation Leads in Subjects with Heart Failure Resulting from Systolic Dysfunction: FIX-HF-5
Sponsor	Impulse Dynamics
Description	The OPTIMIZER III System is a system capable of delivering non-excitatory cardiac contractility modulation (CCM) signals. These electrical signals are intended to influence myocardial properties in patients with chronic heart failure. The system consists of an implantable pulse generator with specialized internal components that generate the CCM signal as well as three commercially available leads, one placed in the right atrium and two placed in the right ventricle. Patients are randomized to receive the device vs. control group.
Further Information	www.impulse-dynamics.com Jessica Wolfe, RN Inova Research Center Inova Fairfax Hospital 703 776-3567 Marie Blake, RN Inova Research Center Inova Fairfax Hospital 703 776-2302

Trial Name	Navistar Thermocool Evaluation of the Catheter with the Stockert 70 Radiofrequency Generator for Endocardial Ablation in Patients with Typical Atrial Flutter , Condition of Approval Study PMA #P030031
Sponsor	Biosense Webster
Description	This study is for patients with symptoms of typical atrial flutter. The Navistar Thermocool Catheter is a FDA approved ablation catheter that has an internal lumen connected to open conduits at the tip electrode for infusion of heparinized saline during the ablation. This objective of this study is to provide additional, corroborative safety and efficacy data for the Navistar Thermocool Catheter.
Further Information	Jessica Wolfe, RN Inova Research Center Inova Fairfax Hospital 703 776-3567 Marie Blake, RN Inova Research Center Inova Fairfax Hospital 703 776-2302

Trial Name	Randomized Evaluation of Long term anticoagulant therapy (RE-LY) comparing the efficacy and safety of two blinded doses of dabigatran etexilate with open label warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation: prospective, multi-centre, parallel-group, non-inferiority trial (RE-LY STUDY)
Sponsor	Boehringer Ingelhem
Description	The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.
Further Information	Andrea Doctor, RN Inova Research Center Inova Fairfax Hospital 703-776-3228 Jessica Wolfe, RN Inova Research Center Inova Fairfax Hospital 703-776-3567 Marie Blake, RN Inova Research Center Inova Fairfax Hospital 703-776-2302

Trial Name	NaviStar ThermoCool Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation (PAF)
Sponsor	Biosense Webster
Description	The purpose of this clinical investigation is to demonstrate that the NaviStar ThermoCool catheter can be used safely and effectively for the ablation treatment of subjects with symptomatic PAF who are refractory to or intolerant of antiarrhythmic drugs (AAD).
Further Information	Andrea Doctor, RN Inova Research Center Inova Fairfax Hospital 703-776-3228 Jessica Wolfe, RN Inova Research Center Inova Fairfax Hospital 703-776-3567

Trial Name	BLOCK-HF The study of Bi-Ventricular versus Right Ventricular pacing in Heart Failure patients with AV Block
Sponsor	Medtronic, Inc
Description	The purpose of this study is to determine if patients with mild to moderate heart failure and some ventricular dysfunction and AV block will benefit from bi-ventricular pacing compared to right ventricular
Further Information	Marie Blake, RN Inova Research Center Inova Fairfax Hospital 703-776-2302

Trial Name	STOP-AF: A Randomized, Controlled Clinical Trial of catheter Cryoablation in the Treatment of Paroxymal Atrial Fibrillation ( PAF)
Sponsor	CryoCath Technologies Inc.
Description	This is a randomized controlled study of patients with PAF referred for ablation after failing one or more antiarrhythmic drugs used in the treatment of atrial fibrillation.
Further Information	Marie Blake, RN Inova Research Center Inova Fairfax Hospital 703-776-2302 Jessica Wolfe, RN Inova Research Center Inova Fairfax Hospital 703-776-3567

Trial Name	GAMMA - A Novel Drug Study on the Effects of Ventricular tachyarrhythmia Induction
Sponsor	Wyeth
Description	Multicenter randomized double blind study to evaluate the effect of a new drug on the inducibility of ventricular tachyarrhythmia in subjects with left ventricular dysfunction and ischemic heart disease.
Further Information	Marie Blake, RN Inova Research Center Inova Fairfax Hospital 703-776-2302 Jessica Wolfe, RN Inova Research Center Inova Fairfax Hospital 703-776-3567