Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT04614402
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04614402
Study Brief:
Protocol Section:
NCT04614402