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Clinical Trials

Our Heart Institute's physician-scientists are committed to excellence in research, in order to find new and better ways to treat heart disease — all part of our commitment to excellence in patient care. Clinical trials test new ways to prevent, diagnose or treat various diseases and conditions.

By taking part in a clinical trial, you will have the possibility of gaining access to new treatments before they're widely available. You also will have the support of a team of cardiac specialists, who will monitor your health closely.

Participation in our clinical trials is always completely voluntary, and never interferes with the normal standards for patient care. Patients participate in our clinical trials only after they receive a complete explanation of their options from their cardiologist or surgeon.

Talk with your cardiologist to learn more about how clinical trials work and whether participating in one is right for you. Below is a listing of some of our current trials:

ARRHYTHMIA

Multicenter:

  • VEST/PREDICTS: A study to see if an external automatic defibrillator vest will reduce overall mortality in the first 60 days following an MI in patients with EF < 35%. Principal investigator: Eric J. Rashba, MD
  • Protego: To determine the long-term safety and reliability of BIOTRONIK’s ProtegoDF4 lead, as used in conjunction with a BIOTRONIK DF4 compatible implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) pulse generator. Principal investigator: Eric J. Rashba, MD
  • Cabana: To determine if catheter ablation is superior to antithrombotic medication in eliminating atrial fibrillation. NIH STUDY. Principal investigator: Eric J. Rashba, MD
  • Tacticath: To evaluate the safety and effectiveness of the TactiCath Quartz Percutaneous Ablation Catheter in the treatment of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated radiofrequency ablation. Principal investigator: Roger Fan, MD
  • SICD-PAS: To determine long term safety and effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and Q-TRAK electrode in a commercial clinical setting. Principal investigator: Eric J. Rashba, MD
  • Adapt Response: The purpose of this study is to test the hypothesis that market released CRT devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) conduction and left bundle branch block (LBBB). Principal investigator: Eric J. Rashba, MD
  • LSS: To evaluate, document and report on the appropriate clinical performance, the long-term reliability and the functional integrity of the 4-SITE Lead/Header System. Principal investigator: Eric J. Rashba, MD
  • Quadripolar: To evaluate the acute and chronic performance of a Quadripolar CRT-D device system in patients indicated for cardiac resynchronization therapy. Principal investigator: Eric J. Rashba, MD
  • Navigate: To determine the safety, performance and effectiveness of the ACUITY™ X4 quadripolar coronary venous leads and the RELIANCE 4-FRONT™ ventricular defibrillation leads to satisfy FDA requirements for premarket submission. Additionally, data from this study will be used to support post-market approval requirements for the ACUITY X4 and RELIANCE 4-FRONT leads. Principal investigator: Eric J. Rashba, MD
  • GLORIA-AF: To investigate the patient’s characteristics influencing the choice of antithrombotic treatment for the prevention of stroke in non-valvular atrial fibrillation (AF) patients and to collect outcome events. Principal investigator: Eric J. Rashba, MD

Site Initiated:

  • Bariatric: To understand the effects of bariatric (weight loss) surgery on the electrical activity of the heart. Principal investigator: Eric J. Rashba, MD
  • Cardiac surgery: To understand the effects of insulin resistance on the electrical activity of the heart. Principal investigator: Eric J. Rashba, MD
  • Haptic Feedback: To collect physiologic data that will enable training physicians with an enhanced ability to appreciate catheter and cardiovascular tissue properties and palpate the effect of catheter contact on moving biological tissue. Principal investigator: Eric J. Rashba, MD

HEART FAILURE

  • Prohibit-Sodium: Study to examine dietary sodium intake and outcomes in heart failure. Principal investigator: Javed Butler, MD
  • INDIE-HFpEF: Study of inorganic nitrite delivery to improve exercise capacity in HFpEF. Principal investigator: Javed Butler, MD
  • REPORT-HF: International registry to assess medical practice with longitudinal observation for treatment of heart failure. Principal investigator: Hal A. Skopicki, MD
  • CHAMP-HF: Observational Registry of Treatment Patterns in U.S. Heart Failure Patients with Reduced Ejection Fraction. Principal investigator: Hal A. Skopicki, MD
  • PREVENT II: Prevention of non-surgical bleeding by management of HeartMate II Patients without antiplatelet therapy. Principal investigator: Hal A. Skopicki, MD
  • PANTHEON: A multicenter, randomized, placebo-controlled, parallel group, double blind, dose-finding phase II trial to study the efficacy, safety, pharmacokinetic and pharmacodynamic effects of the oral partial adenosine A1 receptor agonist neladenoson bialanate over 20 weeks in patients with chronic heart failure with reduced ejection fraction. Principal investigator: Hal A. Skopicki, MD
  • VICTORIA: A randomized parallel-group, placebo-controlled, double-blind, event-driven, multicenter pivotal phase III clinical outcome trial of efficacy and safety of the oral sGC stimulator vericiguat in subjects with heart failure with reduced ejection fraction (HFrEF) - VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction. Principal investigator: Hal A. Skopicki, MD
  • LIFE-HF. EntrestoTM (LCZ696) in advanced heart failure. Principal investigator: Hal A. Skopicki, MD

CARDIO-ONCOLOGY

To learn more about our clinical trials, please call (631) 44-HEART (444-3278).