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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

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

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FINEARTS-HF: This study evaluates the effectiveness and safety of a medication, finerenone, on morbidity and mortality in participants with heart failure (NYHA II-IV) and left ventricular ejection fraction ≥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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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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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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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 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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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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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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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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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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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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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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PROTECT IV: This study assesses if using the Impella® CP (or Impella® 2.5) device during a high-risk coronary angioplasty in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care.

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SMART: This clinical trial reviews valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in people with a small aortic annulus and symptomatic severe native aortic stenosis.

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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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