NCT06833476 TTVR STRONG Under Coverage With Evidence Development (CED) Study
| NCT ID | NCT06833476 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Edwards Lifesciences |
| Condition | Tricuspid Regurgitation |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,044 participants |
| Start Date | 2025-03-19 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,044 participants in total. It began in 2025-03-19 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06833476 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Tricuspid Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06833476 currently recruiting?
Yes, NCT06833476 is actively recruiting participants. Contact the research team at TMTT_GHER_EVIDENCE@edwards.com for enrollment information.
Where is the NCT06833476 trial being conducted?
This trial is being conducted at Irvine, United States.
Who is sponsoring the NCT06833476 clinical trial?
NCT06833476 is sponsored by Edwards Lifesciences. The trial plans to enroll 2,044 participants.