Clinical Trials

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 and Drug Administration (FDA), clinicians, scientists and industry representativescollapse
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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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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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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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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Prospective, randomized, parallel-controlled, multicenter clinical evaluation of the Portico re-sheathable 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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For additional information on this trial please contact Dr. Abeel Mangi, MDLynn Wilson, RN, or Maureen Legenos, RN.collapse
The study is designed to characterize the safety and effectiveness of the Heartmate-3 LVAD in ridge to transplantation patients. The study’s primary endpoints are survival to cardiac transplantation or survival to 180 days on the device while remaining transplant listed UNOS status 1A or 1B, survival to explant for myocardial recovery with the patient surviving to 60 days after device removal or hospital discharge, whichever is longer, without requirement for subsequent mechanical support (such as LVAD,IABP, extracorporeal membrane oxygenation)

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 Evolut-R 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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Prospective, randomized, parallel-controlled, multicenter clinical evaluation of the GLX treatment system for the treatment of clinically significant aortic stenosis in surgical subjects

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