ProjektMiCLASP PMCF Study – Transcatheter Repair of Mitral Regurgitation with Edwards PASCAL Transcatheter Valve Repair…
Grunddaten
Akronym:
MiCLASP PMCF Study
Titel:
Transcatheter Repair of Mitral Regurgitation with Edwards PASCAL Transcatheter Valve Repair System: A European prospective, multicenter Post Market Clinical Follow up.
Laufzeit:
22.01.2021 bis 30.06.2027
Abstract / Kurz- beschreibung:
Study Hypothesis
The Edwards PASCAL Transcatheter Valve Repair System will reduce the severity of MR at discharge, with durable performance at 12 months and improvements in functional status as determined by changes in 6MWD, NYHA classification and quality of life.
Study Objectives
The objectives of this clinical study are to collect data on the safety of the Edwards PASCAL Transcatheter Valve Repair System and on the effectiveness of the PASCAL System in improving MR and improving functional status and quality of life in a post market setting.
Study Design and Methods
Multi-center single arm prospective study. Patients will be followed for up to 5 years.
The Edwards PASCAL Transcatheter Valve Repair System will reduce the severity of MR at discharge, with durable performance at 12 months and improvements in functional status as determined by changes in 6MWD, NYHA classification and quality of life.
Study Objectives
The objectives of this clinical study are to collect data on the safety of the Edwards PASCAL Transcatheter Valve Repair System and on the effectiveness of the PASCAL System in improving MR and improving functional status and quality of life in a post market setting.
Study Design and Methods
Multi-center single arm prospective study. Patients will be followed for up to 5 years.
Beteiligte Mitarbeiter/innen
Leiter/innen
Medizinische Universitätsklinik und Poliklinik (Department)
Kliniken und klinische Institute, Medizinische Fakultät
Kliniken und klinische Institute, Medizinische Fakultät
Ansprechpartner/innen
Medizinische Fakultät
Universität Tübingen
Universität Tübingen
Medizinische Fakultät
Universität Tübingen
Universität Tübingen
Lokale Einrichtungen
Abteilung Innere Medizin III
Medizinische Universitätsklinik und Poliklinik (Department)
Kliniken und klinische Institute, Medizinische Fakultät
Kliniken und klinische Institute, Medizinische Fakultät
Geldgeber
Irvine, Katalonien, Vereinigte Staaten