Comparsion of the current two available TEER systems, the MitraClip with the PASCAL repair system in terms of their effectiveness and safety in patients with degenerative mitral regurgitation (DMR) and in patients with functional regurgitation (FMR), who were referred for an interventional therapy by the heart team due to a high surgical risk profile.
A prospective single-center, open-label study to evaluate the safety and effectiveness of transcatheter mitral valve repair of the mitral valve (M-TEER) using the Edwards PASCAL Transcatheter Valve Repair System compared to using the Abbott MitraClip in patients with severe and symptomatic degenerative or functional mitral regurgitation (FMR). The type of device system used was not randomized but was determined by the operational structuring of our mitral valve program such that patients were scheduled for the next available implantation date with weekly alternating time slots for MitraClip device and PASCAL device. Treating physicians had no influence on scheduling or system selection. Follow-up examinations will be performed one month and one year after the procedure with assessment of echocardiographic and functional status based on the New York Heart Association (NYHA) grade. Patient characteristics, baseline data, and data related to the procedure were assessed using a registry, medical records and the procedure protocols. This study is a subproject of the MitraClip® Registry (NCT02033811)
Study Type
OBSERVATIONAL
Enrollment
214
transcatheter mitral valve repair of the mitral valve (M-TEER) using the Edwards PASCAL Transcatheter Valve Repair System or the Abbott MitraClip in patients with severe and symptomatic degenerative or functional mitral regurgitation (FMR). The type of device system used was not randomized but was determined by the operational structuring of the mitral valve program such that patients were scheduled for the next available implantation date with weekly alternating time slots for MitraClip device and PASCAL device.
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, Germany
Procedural success
as defined by the Mitral Valve Academy Research Consortium (MVARC)
Time frame: one month after implantation
Composite endpoint of all-cause death and heart failure hospitalization
Time frame: one year after implantation
Grade of Mitral Regurgitation
measured by echocardiography
Time frame: one month and one year after implantation
Functional status
according to New York Heart Association (NYHA) functional class
Time frame: one month and one year after implantation
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