TTVR STRONG Under Coverage With Evidence Development (CED) Study

ConditionTricuspid Regurgitation

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age65+

SponsorEdwards Lifesciences

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Medicare eligible real-world patients with severe, symptomatic tricuspid regurgitation

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

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

Treatment groups

2,044 Participants

are divided into 2 treatment groups

Group A: EVOQUE treated1 intervention

Group B: EVOQUE eligible0 interventions

Trial outcomes

Primary outcomes

Composite (All-Cause Death or Heart Failure Hospitalization)

Time to death or heart failure hospitalization after time zero

Time frame

2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Edwards Lifesciences

Lead sponsor

Source ClinicalTrials.gov

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