ProjektTriCLASP PMCF Study – Transcatheter Repair of Tricuspid Regurgitation with Edwards PASCALTranscatheter Valve…
Grunddaten
Akronym:
TriCLASP PMCF Study
Titel:
Transcatheter Repair of Tricuspid Regurgitation with Edwards PASCALTranscatheter Valve Repair System: A European prospective,multicenter Post‐Market Clinical Follow up
Laufzeit:
22.01.2021 bis 30.06.2027
Abstract / Kurz- beschreibung:
Hypothesis
The Edwards PASCAL Transcatheter Valve Repair System will reduce the
severity of tricuspid regurgitation (TR) at discharge, with durable
performance at 12 months and improvements in functional status as
determined by changes in 6MWT, NYHA classification and quality of life.
Study
Objectives
The objectives of this clinical study are to collect data on the safety and
effectiveness of the PASCAL System in improving TR, 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 tricuspid regurgitation (TR) at discharge, with durable
performance at 12 months and improvements in functional status as
determined by changes in 6MWT, NYHA classification and quality of life.
Study
Objectives
The objectives of this clinical study are to collect data on the safety and
effectiveness of the PASCAL System in improving TR, 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