Clinical Trial TitleClinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT)
National Clinical Trial Number:NCT03433274
Clinical Trial Protocol Description:
The purpose of this study is to evaluate a new investigational device called the Tendyne Transcatheter Mitral Valve System. The Tendyne Transcatheter Mitral Valve System is designed for the treatment of a diseased, damaged or malfunctioning mitral valve (a valve in the heart). This trial will collect information on how safe and effective this device is to treat a leaking mitral valve as compared to the commercially available (approved by the U.S. Food and Drug Administration (FDA)) MitraClip® System. The MitraClip System consists of a delivery catheter and an implantable Clip that is designed to repair the mitral valve by clipping the two leaflets together.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older.
- Have symptomatic, moderate-to-severe or severe mitral regurgitation or severe mitral annular calcification (MAC).
- Have been adequately treated, per applicable standards, for coronary artery disease (e.g., revascularization), left ventricular dysfunction (e.g., cardiac resynchronization therapy) and heart failure.
You will be excluded from the study if any of the following criteria apply to you:
- Have had prior surgical or interventional treatment of the mitral valve involving implantation of prosthetic material (e.g. valve repair or replacement, or MitraClip).
- Are undergoing hemodialysis due to chronic renal failure.
- Have COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use.
- Have had a status 1 heart transplant or prior orthotopic heart transplantation.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.