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Heart Valve Clinical Trials

Cedars-Sinai Heart Institute is currently conducting the following heart valve clinical trials:

Mitral Valve
  • EVALVE EVEREST II: Mitral Valve Clip for Patients with Severe Mitral Regurgitation
Aortic Valve
  • Percutaneous Aortic Valve Implantation in Aortic Stenosis - Partner Trial


EVALVE EVEREST II: Mitral Valve Clip for Patients with Severe Mitral Regurgitation

Principal Investigator: Saibal Kar, MD

IRB Approval Number: 6381

Contact: Diana Remba (310) 423-6586

Recruiting

Summary: The objective of this study is to compare percutaneous repair of the mitral valve using the Mitraclip versus standard open heart surgery in patients with severe mitral valve leakage. It is hoped that the percutaneous approach being a less invasive approach would be safer with lesser morbidity than open heart surgery. There is an additional high risk surgical arm, which is intended to evaluate this novel approach for the treatment of mitral valve leakage in patients who are considered to be very high risk for open heart surgery.

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Percutaneous Aortic Valve Implantation in Aortic Stenosis - Partner Trial

Principal Investigator: Rajendra Makkar MD and Alfredo Trento, MD

IRB Approval Number: 12966

Contact: Mitch Gheorghiu, RN (310) 423-6152

Summary: Symptomatic patients with severe aortic stenosis will be considered for this study. Patients with high risk but operable (Group A) will undergo either (1:1 chance) Aortic Valve Replacement (AVR) surgery or Transcatheter Heart Valve implantation (THV). The objective for this group is to demonstrate that valve implantation procedure (THV) is non-inferior to the gold standard open heart surgery (AVR). Patients considered with even higher risk (non-operable) Group B, will undergo either (1:1 chance) Transcatheter Heart Valve implantation or best medical treatment. The objective for this group is to demonstrate that valve implantation procedure is superior to best medical treatment. Implantation of the transcatheter heart valve may result in improved valvular function, acute alleviation of symptoms and improved morbidity and mortality

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