The CLASP III TR CED Study

Conditions: Tricuspid Regurgitation, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Tricuspid Valve Insufficiency

Sex: All

Ages: 65 Years – N/A

Healthy volunteers: No

Enrollment: 2350

Sponsor: Edwards Lifesciences

Summary

This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair procedure using the PASCAL Precision system.

Eligibility Criteria

Inclusion Criteria: * Medicare eligible patients, 65 years old or older * With at least severe Tricuspid Regurgitation who have either received PASCAL Precision system or been managed medically with no transcatheter or surgical tricuspid valve intervention Exclusion Criteria: * Patients not eligible for Medicare (i.e., under 65 years old) * Patients with less than severe Tricuspid Regurgitation * Patients who have received a transcatheter or surgical intervention other than PASCAL Precision system

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07859709). StuddyBuddy aggregates publicly available trial information.