Featured Studies

Accucinch

Functional mitral regurgitation

This is a multi-center, non-randomized, prospective Early Feasibility Study to evaluate the AccuCinch® Ventricular Repair System in patients with symptomatic heart failure and concomitant functional mitral regurgitation that have stable symptoms on guideline-directed medical therapy
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AccuCinch 5018 PMVI

Functional Mitral Valve Regurgitation after mitral valve intervention

This is a non-randomized, prospective, multi-center Early Feasibility Study of the AccuCinch® Ventricular Repair System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation.
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Augustus

Acute Coronary Syndromes

The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K antagonist, such as warfarin, with or without aspirin.
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BEST-CLI

Critical Limb Ischemia

This study will compare the effectiveness of best available surgical treatment with best available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible for both treatment options.
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BioVentrix

Cardiomyopathy; HF

The Clinical Study of the BioVentrix Revivent TC System for Treatment of Left Ventricular Aneurysms is a prospective, multicenter, dual-arm pivotal study of the BioVentrix Revivent TC System, with 2:1 study vs. active concurrent control group allocation ratio.

The Revivent TC System is indicated for patients referred for surgical treatment of left ventricular scar that is contiguous, and includes both anterior and septal components. Primary and Secondary Effectiveness Endpoints will compare data from the patients treat with the Revivent TC System to a control pool of patients who comply with all aspects of the protocol except scar location and are not treated with the investigational devices but remain on Guideline Directed Medical Therapy (GDMT).
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CardioMEMS HF System Post Approval Study

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

The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial setting.
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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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DAPA HF

Heart Failure

​This is an international, multi-center, parallel group, event-driven, randomized, double-blind, placebo-controlled study in patients with chronic heart failure with reduced ejection fraction, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, for prevention of cardiovascular death or reduction of heart failure events.
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DEFINE PCI

Coronary Artery Disease

This is a pilot study designed to assess the relationship between iFR pullback and the distribution of coronary atheroma/stenosis as assessed by Quantitive Coronary Angiography post angiographically successful Percutaneous Coronary Intervention.
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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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EXPAND Heart Trial

Heart Transplant Candidates

To evaluate the effectiveness of the OCS® Heart to recruit, preserve, and assess donor hearts that may not meet current standard donor heart acceptance criteria for transplantation to potentially improve donor heart utilization for transplantation
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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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HEART-FID

Heart failure with iron deficiency anemia

This is a randomized, double blind, placebo-controlled study to investigate the efficacy and safety of Injectafer® (ferric carboxymaltose) as treatment for heart failure with iron deficiency. Study drug administration will occur as two intravenous doses every six months for duration of study.
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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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Interlude

Moderate to Severe Mitral Regurgitation

The purpose of this study is to assess the safety and performance of the Caisson Interventional Transcatheter MitralValve Replacement (TMVR) system for the treatment of severe symptomatic MitralValve Regurgitation (MR). This study will provide initial information on the safety and performance of this system.
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Low Risk “Bicuspid”

Bicuspic Aortic Valve

The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR.
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Low Risk “CAP”

Aortic Valve Stenosis

The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR.
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LOWER

Homozygous Familial Hypercholesterolemia

This global product exposure registry is a multicentre, long-term, prospective, observational cohort study (exposure registry), designed to evaluate the long term safety and effectiveness of lomitapide.
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MitraClip Expand

Mitral Valve Regurgitation

The MitraClip EXPAND Study (A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices) is designed to confirm the safety and performance of the MitraClip NTR System and MitraClip XTR System.
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OPsumit USers Registry

Pulmonary Hypertension

Evaluating the safety profile of Opsumit in the post-marketing setting will provide further characterization of its use from clinical practice. This study is a prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.
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Orion 10

Hypercholesterolemia

A Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects with Atherosclerotic Cardiovascular Disease (ASCVD) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C)
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PIONEER III

Coronary Artery Disease

​The primary objective of this trial is to compare the safety and efficacy of the SINOMED BuMA Supreme biodegradable coronary stent in patients with up to 3 coronary lesions to either the XIENCE or Promus durable polymer coronary stents.
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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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RADIANCE-II

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-II 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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Reduce LAP-HF II

HFpEF

The Corvia Medical InterAtrial Shunt Device (IASD®) System II is indicated for the improvement in quality of life and reduction of heart failure related symptoms and events in patients with heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF) with elevated left atrial pressures, who remain symptomatic despite standard Guideline Directed Medical Therapy. The implant is supplied preloaded onto a delivery system consisting of a delivery catheter with an integrated handle. The implant is placed across the interatrial septum using a percutaneous trans-catheter approach. The procedure is performed in the cardiac catheterization laboratory by an interventional cardiologist. In the setting of high left atrial pressure, the center barrel section allows L→R flow to decompress the left atrium.
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RESOLUTE ONYX

Coronary Artery Disease

​The purpose of the RESOLUTE ONYX Post-Approval study is to observe the continued performance of the Resolute Onyx stent in real-world more-comer population.
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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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Tendyne MAC

Severe Mitral Annular Calcification

This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of subjects with symptomatic, severe mitral regurgitation and severe mitral annular calcification. Subjects satisfying the study criteria will undergo a procedure to implant the Tendyne mitral valve replacement device.
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Tendyne: Summit

Severe Mitral Regurgitation

Prospective, controlled, multicenter clinical investigation with two trial arms: surgical and non-surgical. Subjects in the surgical arm will be randomized in a 2:1 ratio to the trial device or to conventional mitral valve surgery. Subjects in the non-surgical arm will receive the trial device.
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TRACE

Peripheral artery disease

The purpose of this study is to determine if a FDA approved drug called Vorapaxar (Zontivity) indicated for use along with Aspirin and/or Plavix as prescribed by your doctor, can improve symptoms of intermittent claudication.
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TriCinch

Functional Tricuspid Valve Regurgitation

Patients enrolled in this study with all eligibility criteria confirmed will be implanted with the TriCinch Coil System. This device offers a percutaneous treatment (access through the vein at the groin) to treat the leaking tricuspid valve.
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Triluminate

Tricuspid Valve Regurgitation

The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid regurgitation (TR) in patients currently on medical management and who are deemed appropriate for percutaneous transcatheter intervention. This is a prospective, single arm, multi-center study.
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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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Zenith® p-Branch®

Aortic Aneurysm Abdominal

The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of abdominal aortic aneurysms.
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