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.
The proposed study is a prospective, multi-center, interventional investigation enrolling up to 30 subjects in multiple sites in Latin America and Eastern Europe. The primary objective of this study is to collect preliminary information on the performance and safety of the Pipeline Chordal Repair System in percutaneous reduction of significant mitral regurgitation (MR ≥ moderate) due to primary abnormality of the mitral apparatus \[degenerative MR\].
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Implantation of anchor via transcatheter delivery system to delivery chordal repair system tethering the mitral leaflets to the ventricle
Israeli-Georgian Medical Research Clinic Healthycore, LTD
Tbilisi, Georgia
Sanatorio Italiano
Asunción, Paraguay
Institute for Cardiovascular Diseases Dedinje
Belgrade, Serbia
Institute for Cardiovascular Diseases Vojvodina
Kamenitz, Serbia
Safety at 30 days: freedom from death or intervention resulting from valve dysfunction or the implant procedure at 30 days.
Primary Safety
Time frame: 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
Primary Safety
Time frame: Procedure through 30 days post procedure
Technical successful transcatheter implantation of the Chordal Repair System tethering the mitral leaflets to the ventricle
Technical Success
Time frame: Procedure
Procedural success defined as the successful implant of the device resulting in MR severity of < moderate at 30 days as confirmed by echocardiography.
Procedural Success
Time frame: Procedure through 30 days post procedure
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