NCT06557798 REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
| NCT ID | NCT06557798 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Leeds Teaching Hospitals NHS Trust |
| Condition | Aortic Valve Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 550 participants |
| Start Date | 2024-12-12 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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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 550 participants in total. It began in 2024-12-12 with a primary completion date of 2027-06.
⚠ 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
Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and/or leaking. Although TAVI is a safe and effective treatment for a faulty aortic heart valve, the new TAVI valve will not last forever. Because it is a 'tissue' valve (made from the lining of a cow or pig heart), the valve will fail after a period of time as the tissue degenerates. When the TAVI valve fails, a viable treatment option is to perform a 'Redo TAVI' procedure, implanting a second TAVI valve inside the first failing valve. The main purpose of this study is to carefully evaluate patients being treated by Redo TAVI in order to document the short-term and long-term outcomes of the procedure. The study will also obtain information about which factors predict those outcomes. The study will also assess outcomes in patients who present with TAVI valve failure but are not suitable for Redo TAVI, and instead are treated either by open-heart surgery and surgical aortic valve replacement, or by medical therapy (medication). The study will provide doctors the information they need to understand the best way to treat patients who present with TAVI valve failure, and in particular how to perform Redo TAVI procedures with the best possible outcomes for patients.
Eligibility Criteria
Inclusion Criteria: 1\. Bio-prosthetic Valve Failure (BVF) of a Transcatheter Aortic Valve requiring possible reintervention Exclusion Criteria: 1. Bio-prosthetic Valve Failure due solely to paravalvular aortic regurgitation 2. Active endocarditis 3. Untreated acute valve thrombosis 4. Life-expectancy less than 1 year 5. Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable 6. Pregnant or nursing
Contact & Investigator
Daniel Blackman, MD
PRINCIPAL INVESTIGATOR
Leeds Teaching Hospitals NHS Trust
Frequently Asked Questions
Who can join the NCT06557798 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06557798 currently recruiting?
Yes, NCT06557798 is actively recruiting participants. Contact the research team at dave.pickles@nhs.net for enrollment information.
Where is the NCT06557798 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aarhus, Denmark, Copenhagen, Denmark, Helsinki, Finland and 11 additional locations.
Who is sponsoring the NCT06557798 clinical trial?
NCT06557798 is sponsored by The Leeds Teaching Hospitals NHS Trust. The principal investigator is Daniel Blackman, MD at Leeds Teaching Hospitals NHS Trust. The trial plans to enroll 550 participants.