This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter tricuspid valve repair.
The objectives of this clinical study are to collect data on the safety and effectiveness of the PASCAL System and PASCAL Precision System in improving TR, functional status, and quality of life in a post-market setting.
Study Type
OBSERVATIONAL
Enrollment
300
The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve.
The Edwards PASCAL Precision Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve.
Universitätsklinikum Tübingen Innere Medizin III - Kardiologie und Angiologie
Tübingen, Baden-Wurttemberg, Germany
Universitätsklinikum Ulm Innere Medizin II
Ulm, Baden-Wurttemberg, Germany
Number of patients with major adverse events (MAE rates)
The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days
Time frame: 30 days
Change in tricuspid regurgitation severity (scale of 0-5) by echocardiography
Reduction in TR severity as assessed by TEE pre and post-implant in the procedure room. TR severity compared to baseline will be assessed by TR grade at each follow-up interval.
Time frame: Discharge: defined as discharge or 7 days post-procedure, whichever comes first
Volume overload assessed by serial measurements
Patient edema questionnaire
Time frame: baseline, 30 days, 6 months, 12 months, annually up to 5 years
Volume overload assessed by serial measurements
Body weight in kilogram
Time frame: baseline, 30 days, 6 months, 12 months, annually up to 5 years
Volume overload assessed by serial measurements
Edema Assessment (scale 1+ - 4+) grade correspond to mm
Time frame: baseline, 30 days, 6 months, 12 months, annually up to 5 years
Volume overload assessed by serial measurements
Ankle circumference measurement in cm
Time frame: baseline, 30 days, 6 months, 12 months, annually up to 5 years
Functional class, functional status, and Quality of life as assessed
NYHA classification (I-IV) grade
Time frame: baseline, 30 days, 6 months, 12 months, annually up to 5 years
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Medizinische Klinik I- Campus Grosshadern
München, Bavaria, Germany
Herzzentrum Universitätsklinikum Köln
Cologne, DEU, Germany
Westdeutsches Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie
Essen, Nordrhine Westfalia, Germany
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, North Rhine-Westphalia, Germany
Herzzentrum der Universitätsklinik Bonn
Bonn, North Rhine-Westphalia, Germany
Heart Centre of the University Leipzig
Leipzig, Saxony, Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Thuringia, Germany
UKE Hamburg
Hamburg, Germany
...and 5 more locations
Functional class, functional status, and Quality of life as assessed
6-Minute Walk Test in meter
Time frame: baseline, 30 days, 6 months, 12 months, annually up to 5 years
Functional class, functional status, and Quality of life as assessed
5 Level EQ 5D Questionnaire
Time frame: baseline, 30 days, 6 months, 12 months, annually up to 5 years
Functional class, functional status, and Quality of life as assessed
Kansas City Cardiomyopathy Questionnaire
Time frame: baseline, 30 days, 6 months, 12 months, annually up to 5 years