Clinical Trials

Medtronic is sponsoring a clinical trial for the treatment of certain people with severe aortic stenosis. The trial will study an investigational device for transcatheter aortic valve implantation (TAVI). 

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INTERMACS® is a national registry for patients who are receiving mechanical circulatory support device therapy to treat advanced heart failure. This registry was devised as a joint effort of the National Heart, Lung and Blood Institute (NHLBI), the Centers for Medicare and Medicaid Services (CMS), the Food andDrug Administration (FDA), clinicians, scientists and industry representatives.  The PI is responsible for oversight of data submissions and registry compliance.

For additional information on this trial please contact Dr. Abeel Mangi, MDLynn Wilson, RN, or Maureen Legenos, RN.
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The purpose of this trial is to evaluate the safety and efficacy of surgical ablation versus no surgical ablation for patients with persistent or longstanding persisntent atrial fibrillation undergoing mitral valve operation.

For additional information on this trial please contact Dr. Abeel Mangi, MDLynn Wilson, RN, or Maureen Legenos, RN.
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The purpose of this trial is to evaluate the safety and efficacy of mitral valve repair versus no mitral valve repair for patients with moderate mitral regurgitation in the setting of ischemic heart disease undergoing surgical coronary revascularization.

For additional information on this trial please contact Dr. Abeel Mangi, MDLynn Wilson, RN, or Maureen Legenos, RN.

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Prevention of cardiac allograft vasculopathy usingRituximab therapy in cardiac transplantation. 
To determine the cumulative impact of rituximab on the development of coronaryallograft vasculopathy in heart transplant recipients in the first year post transplant. Using intravascular ultrasound a volumetric measure of CAV will be obtained and quantified by a core lab to compare CAV development in patients treated with rituximab and placebo.

For additional information on this trial please contact Dr. Abeel Mangi, MDLynn Wilson, RN, or Maureen Legenos, RN.
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A prospective, randomized, multicenter, parallel-arm study evaluating the overall efficacy and safety of desensitization therapy on selected patients awaiting heart transplantation. 
The purpose of this research study is to find out if the drug Bortezomib (VELCADE ®), along with a procedure called plasmapheresis, can be effective at desensitization. We will be testing whether this treatment lowers antibody levels, and whether as a result patients have fewer complications while waiting for their transplant.

For additional information on this trial please contact Dr. Abeel Mangi, MDLynn Wilson, RN, or Maureen Legenos, RN.
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The purpose of this investigation is to evaluate the safety and effectiveness of the CentriMag VAS when used in failure-to-wean from cardiopulmonary bypass1patients until the patient can be weaned and: a) no longer requires mechanical circulatory support, b) undergoes heart transplantation or c) undergoes further treatment with a commercially available long-term heart assist system.

For additional information on this trial please contact Dr. Abeel Mangi, MDLynn Wilson, RN, or Maureen Legenos, RN.
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Risk Assessment and Comparative Effectiveness Of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients. Evaluate and compare the effectiveness of HM II LVAD support versus OMM in ambulatory NYHA Class IIIB/IV HF patients who are not dependent on intravenous inotropic support and who meet the FDAapproved indications for HM II LVAD destination therapy.

For additional information on this trial please contact Dr. Abeel Mangi, MDLynn Wilson, RN, or Maureen Legenos, RN.
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The purpose of this observational registry is to determine the freedom from DL infection events in subjects implanted with a HeartMate II LVAD in whom only the silicone portion of the DL is externalized resulting in a silicone skin interface (SSI).

For additional information on this trial please contact Dr. Abeel Mangi, MDLynn Wilson, RN, or Maureen Legenos, RN.
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The goals of this study are to better characterize the trajectories of kidney function and injury in patients receiving VADs, to improve pre-operative identification of patients with improved renal function post-VAD in the short-term, and to assess the contribution of functional and injury-relatedkidney biomarkers on post-VAD mortality.

For additional information on this trial please contact Dr. Abeel Mangi, MDLynn Wilson, RN, or Maureen Legenos, RN.
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Prospective, randomized, parallel-controlled, multicenter clinical evaluation of the MitraClip device for the treatment of clinically significant functional mitral regurgitation in extreme high surgical risk subjects.

For additional information on this trial please contact Dr. Abeel Mangi, MDLynn Wilson, RN, or Maureen Legenos, RN.
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Prospective, randomized, parallel-controlled, multicenter clinical evaluation of the CoreValve catheter based aortic valve for the treatment of clinically significant aortic stenosis in extreme high surgical risk subjects.

For additional information on this trial please contact Dr. Abeel Mangi, MDLynn Wilson, RN, or Maureen Legenos, RN.
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The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.

For additional information on this trial please contact Dr. Abeel Mangi, MDLynn Wilson, RN, or Maureen Legenos, RN.
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