All Studies

Accucinch

Functional mitral regurgitation

The objective of this trial is to evaluate the safety and performance of the investigational AccuCinch System and assess the indices of heart failure and functional mitral regurgitation in symptomatic adult patients with mitral regurgitaion and left ventricular remodeling due to dilated cardiomyopathy (ischemic or non-ischemic etiology), who are of high operative risk.
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Cobra Reduce

Angina and CAD (Coronary Artery Disease)

The purpose of this study is to determine whether patients undergoing coronary intervention that also require oral anticoagulation, receiving the COBRA PzF stent plus 14-day dual anti-platelet therapy (DAPT) have a higher safety and non-inferior outcome for thrombo-embolic events compared to patients receiving the standard FDA-approved drug eluting stent (DES) plus 6-month DAPT.
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CONCERT-HF

Ischemic Cardiomyopathy

Heart failure is a serious and common condition. This National Heart, Lung, and Blood Institute research is designed for people who have developed heart failure as a result of heart muscle damage from a heart attack. The purpose of this research study is to determine whether placing stem cells derived from your own body back in to your heart is safe. This research will also help us learn whether these treatments improve heart function for people such as yourself who are not ideal candidates for other forms of standard therapy.
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dal-GenE

Acute Coronary Syndrome

Evaluate the Effects of DalcetrapibDalcetrapib is a CETP inhibitor which was being developed by Hoffmann–La Roche until May 2012 on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS)Acute Coronary Syndrome.
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DREAM-HF-1

Chronic Heart Failure

The primary objective of this study is to determine whether the investigational transendocardial delivery of allogeneic human bone marrow-derived MPCs (rexlemestrocel-L) is effective for chronic heart failure due to LV systolic dysfunction.
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EVOLVE ShortDAPT

Angina and CAD (Coronary Artery Disease)

  • The study will research the safety of aspirin plus 3 months of a second blood thinner (antiplatelet) medication [clopidogrel (Plavix), or prasugrel (Effient), or ticagrelor (Brilinta)] in people who have a SYNERGY stent and are high risk for bleeding.
  • The coronary stenting procedure that will be performed and the SYNERGY stent you will receive are not investigational.
  • The length of time that you may be prescribed by your doctor to take one of these medications (3 months) is investigational. However, recently issued revised guidelines (2016) suggest that stopping dual antiplatelet therapy (DAPT) after 3 months may be reasonable for subjects at high risk for bleeding, following treatment with drug-eluting stents.

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GALILEO

Post TAVR patients

To assess whether an investigational rivaroxaban-based anticoagulation strategy, following TAVR, compared to an antiplatelet-based strategy is superior in reducing death or first thromboembolic events (DTE).
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GOULD

Hypercholesterolemia

This is a multicenter observational cohort study with both retrospective and prospective data collection components in subjects with ASCVD. The purpose of this study is to better understand cholesterol treatment patterns in the context of a changing landscape in subjects with ASCVD
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HEARTAssist 5

Heart Failure; Cardiac Failure; Congestive Heart Failure; Heart Failure Left-Sided

The purpose of the study is to evaluate the safety and effectiveness of the ReliantHeart HeartAssist 5® VAD System in patients listed for heart transplantation and at risk of death from refractory end-stage heart failure.
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PERIGON Pivotal Trial

Aortic Valve Stenosis

To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.
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Postconditioning II in STEMI

Acute Myocardial Infarction

This study will evaluate change in heart muscle function from baseline to three months and twelve months in participants who present with a heart attack and a completely occluded coronary artery. These subjects will be randomized to receive standard Percutaneous transluminal coronary angioplasty (PTCA)/Stenting to open the artery or routine PTCA/Stenting plus post conditioning. Post conditioning commences immediately upon reperfusion using four cycles of thirty second inflations with a standard angioplasty balloon followed by a thirty seconds of reperfusion. The investigators hypothesize that Postconditioning reduces the size of the heart attack when utilized with successful primary Angioplasty/stent.
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PRECEPT

Persistent Atrial Fibrillation; Arrhythmias

The purpose of this study is to demonstrate the safety and effectiveness of the investigational THERMOCOOL SMARTTOUCH® SF catheter in the treatment of drug refractory symptomatic persistent atrial fibrillation (PsAF) following standard electrophysiology mapping and RF ablation procedures.
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RADIANCE-HTN

Hypertension

Hypertension, or high blood pressure, affects over 1 billion people. Left untreated, high blood pressure can increase your risk of serious health problems such as heart attack, stroke, and kidney failure. Yet nearly 1 in 3 individuals with hypertension struggle to control their blood pressure despite being on medication.

If you and your physician have been unable to control your blood pressure, or are interested in an alternative to daily medications, you may be a candidate for the RADIANCE-HTN Clinical Study. The study is evaluating an investigative minimally-invasive, catheter-based procedure (the Paradise® Renal Denervation System) which may lower your blood pressure and reduce your need for blood pressure medications.
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Roadster 2

Carotid Artery Disease

The ROADSTER 2 Study is intended to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying experience with the transcarotid technique.
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SENECA

Anthracycline Induced Cardiomyopathy

This is a first-in-human study using donor stem cells on people who have decreased heart function due to anthracycline that was used to treat their cancer.
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SMILE™

Heart Failure

Multi center, randomized controlled study, to determine if a significant decrease in the rate of heart failure re-hospitalizations occurs during a follow-up period when investigational ReDS guided treatment is used as an adjunct to standard of care.
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TAVR Low Risk

Aortic Valve Stenosis

Transcatheter Aortic Valve Replacement With the investigational Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement. The use of this system is investigational in this study.
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Tendyne

Severe Mitral Regurgitation

The purpose of this expanded clinical study is to evaluate the performance and safety of the investigational Tendyne Mitral Valve System in severe mitral regurgitation in patients with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise available devices.
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Twelve Intrepid

Mitral Valve Insufficiency

Non-randomized pilot study to evaluate the safety and performance of the investigational Medtronic Twelve Intrepid TMVR System in high risk patients with severe, symptomatic mitral regurgitation.
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VENTRIX

Myocardial Infarction; Heart Failure; Left Ventricular Remodeling

Evaluate the safety and feasibility of investigational VentriGel delivered via endomyocardial injections using NOGA mapping/Myostar catheter to subjects with left ventricular ejection fraction (LVEF) 25 to 45% secondary to MI. Secondary endpoints will look at efficacy variables of ESV, EDV, EF, scar mass.
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WRAP-IT

CIED Related Infection; Interventional; Pacemaker; Defibrillator

The Medtronic TYRX™ Absorbable Antibacterial Envelope is an absorbable sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. The purpose of the absorbable coating is to act as a carrier for the antimicrobial agents.
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