TTVR STRONG Under Coverage With Evidence Development (CED) Study

Part of paid clinical trials in Irvine, California.

Sponsor
Edwards Lifesciences
Study ID
NCT06833476
Status
Recruiting
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Conditions

  • Tricuspid Regurgitation

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 19, 2025
Status verified
Mar 2025
Primary completion
Dec 30, 2027
Completion
Dec 31, 2032

Study Design

Enrollment
2,044 participants (estimated)

Arms

  • Arm: EVOQUE treated
    Medicare patients with at least severe Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Replacement with the EVOQUE device and is identified in the TVT Registry
  • Arm: EVOQUE eligible
    Medicare eligible patients with severe, symptomatic Tricuspid Regurgitation that are identifiable in a commercial claims database linked with electronic health records.

Primary Outcome Measure

Composite (All-Cause Death or Heart Failure Hospitalization) [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Edwards LifesciencesIrvineCalifornia92614

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Edwards Lifesciences· Irvine, CA

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