TTVR STRONG Under Coverage With Evidence Development (CED) Study

NCT06833476 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2044

Last updated 2025-03-28

No results posted yet for this 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 Replacement procedure using the EVOQUE system.

Conditions

  • Tricuspid Regurgitation

Interventions

OTHER

EVOQUE

This is a retrospective, non-randomized study. The decision to intervene by TTVR with the EVOQUE device is made by the heart team.

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-19
Primary Completion
2027-12-30
Completion
2032-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06833476 on ClinicalTrials.gov