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TTVR STRONG Under Coverage With Evidence Development (CED) Study

RECRUITINGSponsored by Edwards Lifesciences
Actively Recruiting
SponsorEdwards Lifesciences
Started2025-03-19
Est. completion2027-12-30
Eligibility
Age65 Years+
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 65 Years+Healthy volunteers accepted
Inclusion Criteria:

Medicare eligible patients who have received an EVOQUE device or are EVOQUE eligible and have at least severe Tricuspid Regurgitation

Exclusion Criteria:

Commercially insured patients who have received an EVOQUE device or are EVOQUE eligible or Medicare eligible patients with less than severe Tricuspid Regurgitation

Conditions2

Heart DiseaseTricuspid Regurgitation

Locations1 site

Edwards Lifesciences
Irvine, California, 92614

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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