Mark Groh — Asheville Heart

Dr. Mark Groh, M.D.

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Mission Health & Hospitals

Studies Von Willebrand Disease
Studies Aortic Valve Stenosis
9 reported clinical trials
16 drugs studied

Affiliated Hospitals

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Mission Health & Hospitals

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Mission Hospital

Clinical Trials Mark Groh, M.D. is currently running

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Accuryn Monitoring System

for Cardiac Surgery

The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients. Physiologic data measurements will be collected from enrolled subjects using electronic medical records and data streams via the Accuryn Monitoring System.

Recruiting

1 award

N/A

4 criteria

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Tendyne Transcatheter Mitral Valve System

for Mitral Regurgitation

Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP). Subjects in the Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-repairable, Severe MAC, and Severe MAC CAP cohorts will receive the trial device. The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) is to evaluate the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification. This randomized controlled trial will provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System will be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who are not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and are also not suitable for transcatheter repair with MitraClip, will be enrolled in the Non-repairable cohort. Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.

Recruiting

1 award

N/A

4 criteria

More about Mark Groh, M.D.

Clinical Trial Related

6 years of experience running clinical trials · Led 9 trials as a Principal Investigator · 2 Active Clinical Trials

Treatments Mark Groh, M.D. has experience with

  • Portico™ NG Valve And FlexNav™ Delivery System
  • Portico™ NG (Navitor) Valve And FlexNav™ Delivery System
  • Navitor Titan Valve (35mm) Valve And Large FlexNav™ Delivery System
  • Evolut FX TAVR System
  • Medtronic Evolut PRO+ TAVR System
  • Navitor Transcatheter Aortic Valve Implantation (TAVI) System

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