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Starting soon Observational

The CLASP III TR CED Study

NCT07859709 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2026-10-15
Last updated
2026-10-06

Condition(s) studied

Tricuspid RegurgitationHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesTricuspid Valve Insufficiency

Investigational drug(s) / intervention(s)

PASCAL Precision system TreatedMedicare Eligible Untreated Patients

PASCAL Precision system Treated: Patients 65 years old or older with at least severe Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair with the PASCAL Precision system.

Medicare Eligible Untreated Patients: Patients 65 years old or older with at least severe Tricuspid Regurgitation who did not receive any transcatheter or surgical tricuspid valve intervention.

Study 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

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Composite (All-Cause Death or Heart Failure Hospitalization) — 2 years
    Time to death or heart failure hospitalization after time zero

Trial sites (1)

FacilityCityRegionStatus
Edwards Lifesciences Irvine California

More Edwards Lifesciences trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07859709 on ClinicalTrials.gov ↗ ← All trials in the USA