The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.
The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System. This is a multi-center, prospective, single-arm Post-Market Clinical Follow up Study.
Study Type
OBSERVATIONAL
Enrollment
150
Transcatheter Tricuspid Valve Repair with Edwards Cardioband TR
Ulm University
Ulm, Bavaria, Germany
Universitätsklinik der Ruhr-Universität Bochum
Bad Oeynhausen, North Rhine-Westphalia, Germany
Herzzentrum der UniKlinik Köln
Cologne, North Rhine-Westphalia, Germany
Procedure Success
Reduction in severity of Tricuspid Regurgitation at discharge.
Time frame: Hospital discharge, 2-7 days post-procedure
Major Adverse Event Rate
Rates of major adverse
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Procedure Success
Reduction in severity of Tricuspid Regurgitation (TR) severity
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Change in Quality of Life - KCCQ
Improvement in Quality of Life as assessed by KCCQ.
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Change in Quality of Life - EQ-5D-5L
Improvement in Quality of Life as assessed by EQ-5D-5L
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Charité - Universitätsmedizin Campus Mitte
Berlin, Germany
Berlin Charité-Benjamin Franklin
Berlin, Germany
Universitätsklinikum Bonn
Bonn, Germany
Herzzentrum Universitätsklinik Dresden
Dresden, Germany
University Hospital Erlangen
Erlangen, Germany
Universitätsmedizin Göttingen, Herzzentrum Göttingen
Göttingen, Germany
Asklepios Klinik St. Georg
Hamburg, Germany
...and 4 more locations