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Research

Access to Heart and Vascular Clinical Studies

At the CentraCare Heart & Vascular Center, we know people take part in research studies for many reasons. Some people want to help others who have cardiovascular problems or play a role in the discovery of new therapies. Others are looking to access groundbreaking treatments, new medications or the latest advancements in medical devices.

Whatever your motivation, you can find a variety of ongoing studies at the CentraCare Heart & Vascular Center. As one of Minnesota's largest heart hospitals, we are one of the few sites in the state with a department dedicated to heart research. Our goal is to find better ways to prevent, diagnose and treat heart disease so you can live better and longer.

For more information about our heart research studies, call 320-251-2700, ext. 57584, or e-mail heartresearch@centracare.com.

What are some current cardiovascular research studies at the CentraCare Heart & Vascular Center?

Prevention Studies

SURPASS-CVOT: The purpose of this trial is to assess the effectiveness and safety of a new diabetes drug, tirzepatide, vs dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.

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VESALIUS-CV: This study assesses the effect of lowering low-density lipoprotein cholesterol (LDL-C) with the medication evolocumab on major cardiovascular events in adults without a prior heart attack or stroke who are at high risk of a cardiovascular event.

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Heart Failure Studies

FINEARTS-HF: This study evaluates the effectiveness and safety of finerenone on morbidity and mortality in participants with heart failure (NYHA II-IV) and left ventricular ejection fraction ≥40% (LVEF≥ 40%).

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GUIDE-HF: This clinical trial seeks to demonstrate the effectiveness of the CardioMEMs HF System in an expanded patient population, including heart failure patients outside of the present indication, but at risk for future heart failure events or mortality.

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PROACTIVE-HF: This study looks at the safety and effectiveness of the Cordella pulmonary artery sensor system in NYHA class III heart failure patients.

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DAPA ACT HF-TIMI 68: This clinical trial involves heart failure patients with reduced ejection fraction (left ventricular ejection fraction [LVEF] ≤40%) who have been stabilized during hospitalization for acute heart failure, evaluating the effect of in-hospital initiation of dapagliflozin versus placebo on the clinical outcome of cardiovascular death or worsening heart failure.

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Device Studies

AltaValve Early Feasibility Study: This study evaluates the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for mortality and morbidity from conventional open-heart surgery.

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Amplatzer PFO: This study confirms the safety and effectiveness of the AMPLATZER PFO Occluder in the post-approval setting.

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CATALYST: This clinical trial evaluates the safety and effectiveness of the Amulet device compared to NOAC therapy in patients with non-valvular atrial fibrillation at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy.

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CHAMPION: This study seeks to determine if left atrial appendage closure with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K antagonist oral anticoagulants (NOACs) in patients with non-valvular atrial fibrillation.

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Early-TAVR: Thisstudy evaluates transcatheter aortic valve replacement compared to surveillance for patients with asymptomatic severe aortic stenosis.

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ECLIPSE: This trial will evaluate orbital atherectomy vs conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES).

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FLASH: This study evaluates the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE).

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MICRA-AV: Medtronic is sponsoring the Micra AV Registry using the Micra AV system for continued surveillance of chronic atrioventricular synchronous pacing as intended through the collection of data based on routine clinical care practice, following commercial release.

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OPTION: The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation.

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RESTORE-EF: This study looks at the intermediate-term clinical outcomes collected from electronic health records of high-risk patients who have previously undergone standard of care prophylactic Impella support for a non-emergent percutaneous coronary intervention (PCI).

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Reveal LINQ Registry: The Reveal LINQ Registry will generate reliable, long-term "real world" data of product performance, economic valuation and site-of-service procedural information.

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If you are interested in participating in any of these cardiovascular clinical trials, please contact us at 320-251-2700, ext. 57584, or at heartresearch@centracare.com.

Are research studies safe?
The CentraCare Heart & Vascular Center Research Department undergoes rigorous review from the CentraCare – St. Cloud Hospital Institutional Review Board (IRB). The purpose of the IRB is to protect the rights and safety of people who volunteer to take part in research studies. To contact the IRB, call 320-251-2700, ext. 55716.

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