Phase
Condition
N/ATreatment
Edwards PASCAL Transcatheter Valve Repair System
Edwards PASCAL Precision Transcatheter Valve Repair System
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient is a candidate for transcatheter tricuspid valve repair as determined by aHeart Team
- TR grade ≥3+ (5 grade classification)
- Patient is eligible to receive the PASCAL device per the current approved indicationsfor use
Exclusion
Exclusion Criteria:
- Tricuspid valve anatomic contraindications, including previous tricuspid valvereplacement
- Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation
- Concurrent medical condition with a life expectancy of less than 12 months in thejudgment of the Investigator
- Any patient considered to be part of a vulnerable population
Study Design
Study Description
Connect with a study center
Universitätsklinikum Ulm Innere Medizin II
Ulm, Baden-Wuerttemberg 89070
GermanySite Not Available
Universitätsklinikum Heidelberg Klinik für Kardiologie, Angiologie, Pneumologie
Heidelberg, Baden-Württemberg 69120
GermanySite Not Available
Universitätsklinikum Tübingen Innere Medizin III - Kardiologie und Angiologie
Tübingen, Baden-Württemberg 72076
GermanySite Not Available
Medizinische Klinik I- Campus Grosshadern
München, Bavaria 81377
GermanySite Not Available
Herzzentrum Universitätsklinikum Köln
Köln, DEU D-50937
GermanySite Not Available
Universitätsklinikum Gießen UKGM
Gießen, Hessen 35392
GermanySite Not Available
Westdeutsches Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie
Essen, Nordrhine Westfalia 45147
GermanySite Not Available
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, North Rhine Westphalia 32545
GermanySite Not Available
Herzzentrum der Universitätsklinik Bonn
Bonn, North Rhine Westphalia 53127
GermanySite Not Available
Herzzentrum der Universitätsklinik Bonn
Nonn, North Rhine Westphalia 53127
GermanySite Not Available
Helios Klinikum Siegburg
Siegburg, North Rhine Westphalia, 53721
GermanySite Not Available
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Mainz, Rhineland-Palatinate 55131
GermanySite Not Available
Heart Centre of the University Leipzig
Leipzig, Saxony 04289
GermanySite Not Available
Zentralklinik Bad Berka GmbH
Bad Berka, Thuringia 99437
GermanySite Not Available
Kath. Marienkrankenhaus Hamburg gGmbH
Hamburg, 22087
GermanySite Not Available
UKE Hamburg
Hamburg, 20246
GermanySite Not Available
University Heart Center Lübeck
Lübeck,
GermanySite Not Available
Hygeia Hospital
Athens, 151 23
GreeceSite Not Available
Ospedale del Cuore "G. Pasquinucci"
Massa,
ItalySite Not Available
Inselspital
Bern, 3010
SwitzerlandSite Not Available
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