A multi-center evaluation of the Pipeline chordal repair system for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve repair.
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Safety at 30 days: freedom from death or intervention resulting from valve dysfunction or the implant procedure at 30 days.
Timeframe: Procedure through 30 days post procedure
Freedom from device-related Major Adverse Events (MAE), defined as a combined clinical endpoint of death, reoperation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke or renal failure
Timeframe: Procedure through 30 days post procedure
Technical successful transcatheter implantation of the Chordal Repair System tethering the mitral leaflets to the ventricle
Timeframe: Procedure
Procedural success defined as the successful implant of the device resulting in MR severity of < moderate at 30 days as confirmed by echocardiography.
Timeframe: Procedure through 30 days post procedure