Randomized Evaluation for Failed TAVR

Официальное название

Randomized Evaluation of Valve-In-Valve Versus Explantation for Failed TAVR (REVIVE-TAVR)

Обзор

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

Вмешательства

• Процедура TAVR-explant
  Surgical explantation of failed THV followed by surgical aortic valve replacement and any other cardiac surgeries deemed necessary.
• Устройство Redo-TAVR
  Repeat transcatheter aortic valve implantation within a failed THV.

Первичные конечные точки

• Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes [Срок оценки: 30 days]
• Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes [Срок оценки: 12 months]

Вторичные конечные точки (12)

• All-cause mortality [Срок оценки: 30 days]
• All-cause mortality [Срок оценки: 12 months]
• Stroke [Срок оценки: 30 days]
• Stroke [Срок оценки: 12 months]
• Rehospitalization for cardiovascular causes [Срок оценки: 30 days]
• Rehospitalization for cardiovascular causes [Срок оценки: 12 months]
• Reintervention hospital length of stay (days) [Срок оценки: 30 days]
• Cardiovascular mortality [Срок оценки: 30 days]
• Cardiovascular mortality [Срок оценки: 12 months]
• VARC-3 bleeding [Срок оценки: 30 days]
• VARC-3 bleeding [Срок оценки: 12 months]
• Vascular and access-related complications [Срок оценки: 30 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06400342 · REVIVE-TAVR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗