NCT06400342Not yet recruiting
Randomized Evaluation for Failed TAVR
Randomized Evaluation of Valve-In-Valve Versus Explantation for Failed TAVR (REVIVE-TAVR)
Source: ClinicalTrials.gov · Last updated 24 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
REVIVE TAVR is an acronym for the Randomized Evaluation of Valve-In-Valve versus Explantation for failed TAVR. This is a prospective, multicenter, global randomized trial investigating the safety and efficacy of reintervention for transcatheter heart valve (THV) failure by comparing redo-TAVR (TAV-in-TAV) with TAVR surgical explantation (TAVR-explant) in subjects who are suitable for both options in a real-world clinical setting
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 264 (estimated)
- First submitted
- 25 Mar 2024
- Start date
- 1 Mar 2025
- Primary completion date
- 1 May 2034
- Lead sponsor
- Medstar Health Research Institute
- NCT number
- NCT06400342
What you commit to
- Study type: Interventional
- Planned participants: 264
- From 1 Mar 2025 to the primary completion date, 1 May 2034
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits);
- Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams;
Other
- Ongoing sepsis, including active endocarditis;
- Pregnancy or intent to become pregnant for the next 12 months;
- Coronary obstruction risk:
- \- Patients at risk of coronary obstruction may be enrolled into the randomized cohort if the operators determine that redo-TAVR can be safely accomplished with leaflet modification or other coronary protection strategies.
Who the study is looking for
- Heart Team has confirmed eligibility for both TAVR-explant and redo-TAVR for failed THV
- Subject is symptomatic from their failed THV, as demonstrated by NYHA Functional Class ≥II
- Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
- Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.