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, many of them regional leaders in their field, have participated in more than 70 clinical research studies in the areas of interventional cardiology, electrophysiology, peripheral vascular and carotid disease.

Current Research Studies

Coronary Artery Disease

TURBULENCE:  The purpose of the study is to compare how the CADence™ device detects stenosis (abnormal narrowing) in the coronary arteries as compared to a nuclear stress test.  The CADence™ device is a non-invasive, hand-held device that that is placed on the chest and detects acoustic waves (sound waves) which may be linked to coronary artery disease.  We are actively enrolling patients now.  For questions, please contact Molly Graham, RN at 763-236-9167.

SILVER AMI:  The goal of this research study is to help the researcher and doctor better understand recovery after hospitalization. The researchers will gather information that may be used to predict recovery of older persons after a heart attack.  We are actively enrolling patients now.  For questions, please contact Molly Graham, RN at 763-236-9167.

GORE:  The purpose of this Research Study is to determine the safety and effectiveness of the GORE® EXCLUDER® Iliac Branch Endoprosthesis when used for Common Iliac Artery Aneurysms or Aorto-Iliac Aneurysms. We are actively enrolling patients now.  For questions, please contact Shelly Bloch, RN at 763-236-9347.

ALLSTAR:  The purpose of this study is to determine the safety and efficacy of Intracoronary Delivery of Allogeneic Cardiosphere-Derived Cells in patients with an Anterior Myocardial Infarction and Ischemic Left Ventricular Dysfunction.   We are actively enrolling patients now.  For questions, please contact Molly Graham, RN at 763-236-9167.

 

Peripheral Artery Disease

DURABILITY PAS:   This post-approval study is designed to confirm the long-term safety and effectiveness of the EverFlex™ Self-Expanding Stent System for the treatment of atherosclerotic superficial femoral artery and proximal popliteal arteries (blood vessels in the legs). The stent is designed to be easier to place, fracture resistant and improve blood flow through the vessel.  We are actively enrolling patients now. For questions, please contact Shelly Bloch, RN at 763-236-9347.

LIBERTY:  This is a prospective, observational, multi-center, clinical study examining predictors of clinical outcomes for patients undergoing endovascular treatment of lesions within or extending into the target area. This includes disease in a vessel located within or extending into the distal superficial femoral artery, popliteal, tibial peroneal trunk, anterior tibial, posterior tibia, and peroneal tibial arteries.  We are actively enrolling patients now.  For questions, please contact Shelly Bloch, RN at 763-236-9347.

 

Cardiac Rhythm Management

Product Performance Platform (PPP):  The purpose of this study is to collect information over time regarding how Medtronic market-released cardiac therapy products are working.   We are actively enrolling patients now.   For questions, please contact Brittany Renier, RN at 763-236-9134

NAVIGATE:  The objective of the NAVIGATE X4 Clinical Study is to gather data to establish 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 pre-market submission. Additionally, data from this study will be used to support post-market approval requirements for the ACUITY X4 and RELIANCE 4-FRONT leads.  We are actively enrolling patients now.  For questions, please contact Brittany Renier, RN at 763-236-9134

S-ICD PAS: The purpose of the S-ICD Post Approval Study is to document 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. The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.  We are actively enrolling patients now.  For questions, please contact Brittany Renier, RN at 763-236-9134.

 

Heart Failure

PARAGON:   The purpose of this study is to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure (HF) hospitalizations in patients with HF with preserved ejection fraction.  We are actively enrolling patients now.  For questions, please contact Molly Graham, RN at 763-236-9167.

CARDIOMEMS:  The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a real life clinical setting.  We are actively enrolling patients now.  If you are interested in participating, please contact Molly Graham, RN at 763-236-9167.