The clinical trials groups within the Division of Cardiology bridge the realm of bench science with that of daily clinical care rendered to patients within our healthcare system. Through clinical trials, its investigators and trials staff provide the mechanism for the collection of data to determine the efficacy and safety of new pharmaceuticals and devices. Trial recruitment and management is critical to the success of the program, and relies heavily on the independent work of study coordinators. Ethical considerations must be paramount, as our first priority is patient safety – therefore there are significant regulatory requirements (internal to the university, as well as to numerous external agencies).

There are two distinct groups managing clinical trials within the Division of Cardiology – the heart failure group and the cardiology clinical trials group. In addition, several faculty members’ work on investigator initiated research, employing clinical and administrative staff, interns, and work study students to assist. The cardiology clinical trials group manages a complex array of industry-sponsored, federally-funded, and investigator-initiated trials across the various disciplines within cardiology, including cardiac electrophysiology, interventional cardiology, advanced heart failure, and general cardiology. Provided below is a listing of the current clinical trials run through the cardiology clinical trials group.

For additional information on ongoing clinical research in the Division of Cardiology, please contact  (for cardiology clinical trials group) or  (for Adams heart failure group).

Cardiology Clinical Trials Group Studies by Subspecialty

Cardiac Electrophysiology

  • Accent MRI Pacemaker and Tendril MRI Lead IDE Study – Accent MRI™ Pacemaker and Tendril MRI™ Lead IDE Study
  • CABANA – Catheter Ablation Versus Anti-Arrhythmic Drug therapy for Atrial Fibrillation Trial
  • ENABLE MRI – Expanding MRI Access for Patients with New and Existing ICDs and CRT-Ds
  • NAVIGATE X4 – Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads
  • QP ExCELs – Sentus QP – Extended CRT evaluation with Quadripolar Left Ventricular Leads
  • Quad PAS – Quadripolar Pacing Post Approval Study
  • UNTOUCHED – Understanding Outcomes with the EMBLEM™ S-ICD in Primary Prevention Patients with Low Ejection Fraction
  • Vest – Vest Prevention of Early Sudden death Trial and VEST Registry
  • ZERO AF – Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

General Cardiology

  • AUGUSTUS – An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients with Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention
  • MINT – Myocardial Ischemia and Transfusion Trial
  • PARADISE-MI – Prospective ARNI versus ACE inhibitor trial to determine superiority in reducing heart failure events after myocardial infarction

Interventional Cardiology

  • RADIANCE HTN – A study of the ReCor Medical Paradise® Renal Denervation System in Clinical Hypertension

Structural Heart

  • PORTICO – Portico™ Re-sheathable Transcatheter Aortic Valve System US IDE Trial

Advanced Heart Failure and Transplantation

  • MOMENTUM 3 IDE Study – Multicenter Study of MagLev Technology in Patients Undergoing MCS Therapy with HeartMate3™
  • MOMENTUM 3 CAP – Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy with HeartMate3™ Continued Access Protocol
  • PREVENT II – PREVENTion of Non-Surgical Bleeding by Management of HeartMate II Patients without Antiplatelet Therapy
  • SSI Registry – Driveline Silicone Skin Interface Registry Protocol

Adams Heart Failure Research Group Clinical Trials

  • GALACTIC-HF – A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction
  • VICTORIA – A Randomized Parallel-Group, Placebo-Controlled, Double-Blind, Event- Driven, Multi-Center 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
  • PIONEER-HF – A multicenter, randomized, double-blind, double dummy, parallel group, active-controlled 8-week study to evaluate the effect of sacubitril/valsartan (LCZ696) versus enalapril on changes in NT-proBNP and safety and tolerability of in-hospital initiation of LCZ696 compared to enalapril in HFrEF patients who have been stabilized following hospitalization for acute decompensated heart failure (ADHF)
  • TROUPER – Tolvaptan For Worsening Outpatient Heart Failure: Role of Copeptin In Identifying Responders