Research

Enroll in a Heart and Vascular Research Study

At the CentraCare Heart & Vascular Center, we know people take part in clinical 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

DAL-GENE-2: This study evaluates the potential of dalcetrapib to reduce the occurrence of fatal and non-fatal heart attacks in patients with a documented recent acute coronary syndrome (ACS) and the AA genotype at variant rs1967309 in the ADCY9 gene.

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INCEPTION: This study reviews the effectiveness of a systematic LDL-C management pathway, including treatment with inclisiran, in participants who had a recent acute coronary syndrome (ACS) and have an increased LDL-cholesterol (≥70 mg/dL) despite being treated with a statin drug.

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TANDEM: The study evaluates the efficacy, safety and tolerability of an obicetrapib 10mg and ezetimibe 10mg fixed dose combination as an adjunct to diet and maximally tolerated lipid-lowering therapy in people with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors.

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VICTORION-2P: The purpose of this pivotal Phase III clinical trial is to evaluate the benefits of the drug inclisiran on major adverse cardiovascular events in participants with established cardiovascular disease.

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Heart Failure Studies

DAPA-ACT: This clinical trial looks at patients who have been stabilized during hospitalization for acute heart failure and evaluates 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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EMPOWER: This clinical trial assesses the safety and efficacy of the Carillon Mitral Contour System in treating heart failure patients who have early-stage functional mitral regurgitation (FMR).

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SWAN: This study seeks to understand the feasibility of characterizing walking patterns in heart failure subjects and subjects at risk for arrhythmias using an investigational wearable monitor called the SWAN study system.

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TRIBE-HF: This study assesses readmission reduction and quality of life improvement of heart failure patients through the use of the CardioID remote patient monitoring (RPM) platform.

VENUS-HF: This study evaluates the safety and performance of the preCARDIA System for patients with acute decompensated heart failure (ADHF).

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Device Studies

ACURATE IDE: This study evaluates the safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in people with severe native aortic stenosis.

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ALLIANCE: This study establishes the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in people with symptomatic, severe, calcific aortic stenosis (AS).

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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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AVENTUS: This study evaluates the safety and efficacy of the Aventus Thrombectomy System for aspiration thrombectomy in people with acute pulmonary embolism.

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CATALYST: This clinical trial evaluates the safety and effectiveness of the Amulet device compared to novel oral anticoagulant (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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COMPLETE TAVR: Among patients who have undergone a successful elective transfemoral TAVR, this study will determine whether a strategy of complete revascularization involving staged PCI using drug eluting stents to treat all suitable coronary lesions is superior to a strategy of medical therapy alone in reducing the composite outcome of cardiovascular death, new heart attack, ischemia driven revascularization or hospitalization.

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CONFORM: This study evaluates if the CLAAS® device is similar in safety and efficacy to the commercially available WATCHMAN® and Amulet™ left atrial appendage closure devices in patients with non-valvular atrial fibrillation.

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ENCIRCLE: This study will establish the safety and effectiveness of the SAPIEN M3 System in people with symptomatic, at least 3+ mitral regurgitation (MR), for whom commercially available surgical or transcatheter treatment options are deemed unsuitable.

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ECP: This study evaluates the rate of major adverse cardiovascular and cerebrovascular events (MACCE) with the Impella ECP device in adult patients undergoing elective or urgent high-risk percutaneous coronary intervention.

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PEERLESS: This study compares the FlowTriever system to catheter-directed thrombolysis (CDT) for acute intermediate-high-risk pulmonary embolism (PE) and includes a non-randomized group made up of 150 subjects who are not able to receive thrombolytics.

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PROGRESS: This study’s objective is to establish the safety and effectiveness of the Edwards SAPIEN 3/ SAPIEN 3 Ultra Transcatheter Heart Valve in subjects with moderate, calcific aortic stenosis.

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SPYRAL AFFIRM: This study seeks to determine the long-term safety, efficacy and durability of the Symplicity Spyral system in subjects treated with renal denervation. Watch Simplicity Spyral Procedure Animation.

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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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