Penn Heart and Vascular

Clinical Trials at the Cardiac Arrhythmia Program

NIH-Sponsored Trials

CABANA–Catheter Ablation vs. Anti–Arrhythmic Drug Therapy for A–Fib

A multi-center, randomized trial to compare the effect of percutaneous catheter ablation versus current state–of–the–art drug therapy on total mortality among patients with atrial fibrillation. Other important endpoints: stroke, quality of life and healthcare costs.

ARVC Registry

ARVC-NIH sponsored registry of patients with suspected or diagnosed arrhythmogenic right ventricular cardiomyopathy (ARVC) focusing on the genetics, mechanisms and clinical phenotypes during long term follow up.

Atrial fibrillation ablation trials

TactiCath PAS

A multi-center post approval study to assess the safety and efficacy of the contact force sensing catheter during atrial fibrillation ablation.

Zero AF

A randomized multi-center trial to assess safety and efficacy of the Blazer open-irrigated ablation catheter for use during atrial fibrillation ablation .

Smart-SF (pending)

A prospective safety assessment of a contact force sensing catheter during atrial fibrillation ablation.

Oral Anticoagulation Therapy Pilot Study

A multi-center randomized trial to determine the safety of withdrawing oral anticoagulation in patients with high risk for thromboembolism following successful atrial fibrillation ablation.

Ventricular tachycardia (VT) ablation trials

STAR VT

A multi-center, randomized study of VT ablation vs conventional medical therapy in patients with spontaneous or inducible VT (high risk for recurrent episodes) undergoing ICD or CRT-D implant to assess for clinical outcome (reduction in number of ICD shocks for VT).

Pacemaker/implantable defibrillator trials

Adapt Response Study

A prospective randomized multi-center post market Cardiac Resynchronization Therapy (CRT) in heart failure trial.

SIELLO S Lead Study

A pre-market (IDE) study to confirm safety and reliability of pacemaker lead.