Clinical Research

The clinical research program at the Metropolitan Heart and Vascular Institute participates in the advancement of science and medicine through our involvement in research studies. We partner closely with academic centers and industry leaders to answer important questions about treatment and to bring the latest in cutting edge cardiovascular therapy and prevention to our patients.  Over the last decade, our cardiovascular experts have participated in more than 70 clinical research studies in the areas of interventional cardiology, heart rhythm, and vascular disease.

Current Research Studies

Heart Rhythm

CHAMPION-AF.  This study is a prospective, clinical trial which randomizes patients to either the WATCHMAN FLX Left Atrial Appendage Closure Device (“Device Group”) or a commercially available non-vitamin K oral anticoagulant (DOAC).

Extravascular ICD Pivotal Study.  The study is designed to demonstrate safety and efficacy of the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.

Coronary Artery Disease

ONYX Post-Approval Study.  The purpose of this study is to evaluate the safety and effectiveness of the Medtronic Resolute Onyx™ Stent System.

ECLIPSE.  This study evaluates the treatment strategies for severe calcified coronary arteries by comparing the use of orbital atherectomy versus conventional balloon angioplasty prior to stent placement.

Peripheral Artery Disease

RANGER.   This research study compares standard balloon treatment versus drug coated balloon for patients with peripheral vascular disease in their legs.

Research Spotlight: ECLIPSE

Patients with severely calcified coronary arteries are often difficult to treat. Common issues include arteries that are prone to dissection, incomplete expansion of stent and difficult stent placement. Even with second-generation drug-eluting stents, the outcomes in patients with severe coronary calcification are worse than those with non-calcified arteries.

The Eclipse study compares standard treatment of severely calcified lesions with balloons and drug-eluting stents to pretreatment with orbital atherectomy which modifies the calcified plaque prior to stent implantation.

Orbital atherectomy, produced by Cardiovascular Systems Incorporated, uses a unique mechanism of differential sanding that allows the eccentric-coated crown to both rotate in orbit, while sanding the hard materials out such as calcium, and flexing the soft material out of the way.

In the Orbit II trial, orbital atherectomy was compared to historic controls and was found to be a safe and effective in treating severely calcified coronary lesions. Now in the Eclipse study, currently the largest interventional device study being conducted, orbital atherectomy will be tested against the standard of care to determine which strategy produces a better outcome for patients. Metropolitan Heart and Vascular Institute Research Program is currently one of the top 10 enrolling sites for this study.