Dr. Matthew Romano - Heart Surgeon in ...

Dr. Matthew Romano, MD

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University of Michigan

Studies Mitral Regurgitation
Studies Mitral Valve Regurgitation
9 reported clinical trials
12 drugs studied

Affiliated Hospitals

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University Of Michigan
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University Of Michigan Health System

Clinical Trials Matthew Romano, MD is currently running

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Transcatheter Valve Repair

for Mitral Regurgitation

This trial tests a new device called Edwards PASCAL that fixes leaky heart valves without surgery. It is for patients who can't have surgery or haven't improved with other treatments. The device helps the valve close better, stopping blood from leaking backward.
Recruiting1 award N/A9 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.
Recruiting1 award N/A4 criteria

More about Matthew Romano, MD

Clinical Trial Related7 years of experience running clinical trials · Led 9 trials as a Principal Investigator · 4 Active Clinical Trials
Treatments Matthew Romano, MD has experience with
  • Edwards PASCAL System
  • Optimal Medical Therapy
  • Abbott Mitraclip System
  • Tendyne Mitral Valve System
  • MitraClip System
  • HARPOON™ Beating Heart Mitral Valve Repair System

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