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
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.
Ongoing sepsis, including active endocarditis;
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;
Pregnancy or intent to become pregnant for the next 12 months;
Parallel
TAVR-explant
Procedure/SurgerySurgical explantation of failed THV followed by surgical aortic valve replacement and any other cardiac surgeries deemed necessary.
Redo-TAVR
DeviceRepeat transcatheter aortic valve implantation within a failed THV.
Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes
Time to first event of any components of the composite endpoint.
Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes
Time to first event of any components of the composite endpoint.
All-cause mortality
Cardiovascular mortality, Valve-related mortality, Non-cardiovascular mortality
All-cause mortality
Cardiovascular mortality, Valve-related mortality, Non-cardiovascular mortality
Stroke
Stroke
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