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Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System

Active Not RecruitingN/A

Sponsor: Edwards Lifesciences

Conditions: Tricuspid Valve Insufficiency

Interventions: Edwards PASCAL Transcatheter Valve Repair System, Edwards PASCAL Precision Transcatheter Valve Repair System

Countries: Germany, Greece, Italy, Switzerland

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Patient is a candidate for transcatheter tricuspid valve repair as determined by a Heart Team
2. TR grade ≥3+ (5 grade classification)
3. Patient is eligible to receive the PASCAL device per the current approved indications for use

Exclusion Criteria:

1. Tricuspid valve anatomic contraindications, including previous tricuspid valve replacement
2. Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation
3. Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
4. Any patient considered to be part of a vulnerable population

Locations (15)

Tübingen, Baden-Wurttemberg, Germany
Ulm, Baden-Wurttemberg, Germany
München, Bavaria, Germany
Cologne, DEU, Germany
Essen, Nordrhine Westfalia, Germany
Bad Oeynhausen, North Rhine-Westphalia, Germany
Bonn, North Rhine-Westphalia, Germany
Leipzig, Saxony, Germany
Bad Berka, Thuringia, Germany
Hamburg, Germany
Hamburg, Germany
Lübeck, Germany
Athens, Greece
Massa, Italy
Bern, Switzerland