Penn Heart and Vascular

Clinical Trials at the Cardiac Arrhythmia Program

Clinical Trials

Heart Rhythm Disorders

National Heart Lung and Blood Institute (NHLBI) in conjunction with the Cardiothoracic Surgical Trials Network (CTSN)

Surgical Ablation Versus No Surgical Ablation for Patients with Persistent or Longstanding Persistent Atrial Fibrillation Undergoing Mitral Valve Surgery

This study compares the effect of mitral valve surgery alone or in combination with atrial fibrillation ablation on postop heart rhythm in patients with MV disease and persistent or longstanding persistent AF.

  • PI: Michael A. Acker, MD
  • Co-Investigator: Y. Joseph Woo, MD
  • Senior Clinical Research Nurse Coordinator: Mary Lou Mayer, RN
Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF)/Persistent Study

This investigation is a prospective, non-randomized multicenter clinical trial evaluating the outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure.

Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF) Study

A prospective, non-randomized multicenter clinical trial evaluating the outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure.

Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy (PREVAIL)

This is a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology. It is for patients with a form of irregular heartbeat, atrial fibrillation, to test an implantable device in place of a common blood-thinning medication.

S-ICD® System Clinical Investigation

This prospective, non-randomized, multicenter clinical study will evaluate the safety and effectiveness of the Cameron Health subcutaneous implantable defibrillator system (S-ICD® System). Patients will be followed prior to hospital discharge and at regular intervals post-implant until study closure.

DE–MRI Determinant of Successful Radiofrequency Catheter Ablation of Atrial Fibrillation (DECAAF)

This observational study will evaluate the use of delayed–enhancement MRI (DE–MRI) to stage AF and predict outcomes prior to AF ablation procedure; DE–MRI based assessment of chronic atrial structural remodeling, lesion characteristics and correlation with clinical outcomes and recurrences after ablation; and reproducibility in image acquisition, processing and analysis of the infrastructure.

IRASE Study: Irrigated Ablation System Evaluation for AF

The purpose of this clinical study is to test the safety and effectiveness of an irrigated ablation system for the treatment of symptomatic paroxysmal atrial fibrillation (PAF).

Multicenter Automatic Defibrillator Implantation Trial: Reduce Inappropriate Therapy (MADIT–RIT)

This study will compare the occurrence of inappropriate therapy using either high rate cut–off and/or long delay in primary prevention patients receiving ICD or CRT as compared to standard programming.

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

A multicenter, 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.

Assessing Arrhythmias After Ablation Using Implantable Recorders (REVEAL XT)

A randomized, single–blinded trial with patients acting as their own controls to compare the efficacy of a conventional monitoring strategy versus the Reveal XT (ie, implantable loop recorder) in identifying atrial fibrillation recurrence.

ENGAGE AF

The study aims to evaluate whether an investigational drug, edoxaban, is as safe and effective as warfarin in reducing clot formation in patients being treated for atrial fibrillation.