TTVR STRONG Under Coverage With Evidence Development (CED) Study (STRONG)

March 27, 2025 updated by: Edwards Lifesciences

Transcatheter Tricuspid Valve Replacement (TTVR) in Patients With Severe TR ONgoing Evidence Generation (STRONG) Under Coverage With Evidence Development (CED)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a retrospective, non-randomized cohort study measuring 2-year effectiveness of the EVOQUE Transcatheter Tricuspid Valve Replacement (TTVR) system in the real-world.

This study will retrospectively evaluate EVOQUE treated patients in the STS/ACC TVT Registry who have at least severe Tricuspid Regurgitation and can be deterministically linked with Medicare data.

This group will be compared to Medicare eligible and EVOQUE eligible patients evaluated in a standard of care setting from a commercial claims database linked with electronic health records.

We will evaluate the primary outcome measure in various subgroups.

There will be continued access enrollment after the primary completion date.

Study Type

Observational

Enrollment (Estimated)

2044

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
EVOQUE eligible
Medicare eligible patients with severe, symptomatic Tricuspid Regurgitation that are identifiable in a commercial claims database linked with electronic health records.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite (All-Cause Death or Heart Failure Hospitalization)
Time Frame: 2 years
Time to death or heart failure hospitalization after time zero
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2025

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVOQUE CED

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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