Prospective single-arm study of the AccuCinch® Ventriculoplasty System in the treatment of mitral valve regurgitation through subvalvular mitral repair. Purpose: To demonstrate the safety, feasibility and potential efficacy of using the AccuCinch® Ventriculoplasty System to reduce mitral valve regurgitation through subvalvular mitral repair.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
16
Mitral valve repair due to functional disease
Medical University of Vienna
Vienna, Austria
University Hospital Freiburg-Bad Krozingen
Bad Krozingen, Germany
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau, Germany
St.-Johannes-Hospital
Dortmund, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Cardiovascular Center Frankfurt
Frankfurt, Germany
Medical Care Center Hamburg University Cardiovascular Center
Hamburg, Germany
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
Safety through 30 days and reduction in MR acutely and at 30 days.
Time frame: 30 days
Safety and reduction in MR at 1 year.
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.