Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System
Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards
 PASCAL 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 in improving TR, functional status, and quality of life in a post-market
 setting.
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