All Studies

Cobra Reduce

Angina

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

Phase II, randomized, placebo-controlled clinical trial designed to assess feasibility, safety, and effect of investigational autologous bone marrow-derived mesenchymal stem cells (MSCs) and c-kit+ cardiac stem cells (CSCs) both alone and in combination (Combo), compared to placebo as well as each other, administered by NOGA injection in subjects with ischemic cardiomyopathy.
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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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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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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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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

Safety and feasibility study of delivering investigational allogeneic human mesenchymal stem cells (allo-MSCs) via NOGA to cancer survivors with left ventricular (LV) dysfunction secondary to anthracycline-induced cardiomyopathy (AIC).
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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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