Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post-Market Clinical Follow up
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tricuspid Valve Insufficiency
- Sponsor
- Edwards Lifesciences
- Enrollment
- 300
- Locations
- 15
- Primary Endpoint
- Change in tricuspid regurgitation severity (scale of 0-5) by echocardiography
- Status
- Active, not recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient is a candidate for transcatheter tricuspid valve repair as determined by a Heart Team
- •TR grade ≥3+ (5 grade classification)
- •Patient is eligible to receive the PASCAL device per the current approved indications for use
Exclusion Criteria
- •Tricuspid valve anatomic contraindications, including previous tricuspid valve replacement
- •Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation
- •Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
- •Any patient considered to be part of a vulnerable population
Outcomes
Primary Outcomes
Change in tricuspid regurgitation severity (scale of 0-5) by echocardiography
Time Frame: Discharge: defined as discharge or 7 days post-procedure, whichever comes first
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.
Number of patients with major adverse events (MAE rates)
Time Frame: 30 days
The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days
Secondary Outcomes
- Functional class, functional status, and Quality of life as assessed(baseline, 30 days, 6 months, 12 months, annually up to 5 years)
- Volume overload assessed by serial measurements(baseline, 30 days, 6 months, 12 months, annually up to 5 years)