Cardiovascular Diseases Clinical Trial
Official title:
European First in Human Study of the NeoChord Transcatheter Mitral Repair System to Assess Safety and Performance in Patients With Symptomatic Mitral Regurgitation
Safety and performance evaluation of the NeoChord Transcatheter Mitral Repair System in patients with degenerative mitral valve regurgitation.
The objective of this First-in-Human (FIH) evaluation is to assess the safety and performance of the NeoChord Transcatheter Mitral Repair System in treating subjects with symptomatic mitral regurgitation, who are at high risk for standard mitral valve surgery, by using a minimally invasive transcatheter mitral valve repair procedure. The NeoChord Transcatheter Mitral Repair System is indicated for use in patients with grade 3+ or 4+ mitral valve regurgitation who are candidates for surgical mitral valve repair or replacement. The intended purpose for the NeoChord Transcatheter Mitral Repair System is for repair of chordal elongation and rupture resulting in mitral valve prolapse. ;
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