NCT06400342尚未招募不适用
Randomized Evaluation of Valve-In-Valve Versus Explantation for Failed TAVR (REVIVE-TAVR)
Medstar Health Research Institute0 个研究点目标入组 264 人开始时间: 2025年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 264
- 主要终点
- Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Redo-TAVR
Active Comparator
TAV-in-TAV
干预措施: Redo-TAVR (Device)
TAVR-explant
Active Comparator
TAVR surgical explantation
干预措施: TAVR-explant (Procedure)
结局指标
主要结局
Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes
时间窗: 12 months
Time to first event of any components of the composite endpoint.
Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes
时间窗: 30 days
Time to first event of any components of the composite endpoint.
次要结局
- Vascular and access-related complications(12 months)
- Change in NYHA class from Baseline(12 months)
- Cardiovascular mortality(12 months)
- Stroke(12 months)
- All-cause mortality(12 months)
- Change in Quality of life (KCCQ) from Baseline(12 months)
- Rehospitalization for cardiovascular causes(12 months)
- Cardiac structural complications(12 months)
- Acute kidney injury(12 months)
- Echocardiographic assessment of prosthetic valve performance(12 months)
- Reintervention hospital length of stay (days)(30 days)
- Myocardial infarction (adapted from 4th Universal, SCAI, and ARC-2 definitions)(12 months)
- VARC-3 bleeding(12 months)
- Other acute procedural and technical valve-related complications(12 months)
- Bioprosthetic valve dysfunction (BVD) and failure (BVF) as defined by the Valve Academic Research Consortium (VARC)-3 Criteria.(12 months)
- Technical Success(12 months)
- Conduction disturbance requiring permanent pacemaker implantation(12 months)
- Device Success (for Redo-TAVR)(12 months)
- Safety Composite Endpoints(12 months)
- Bioprosthetic valve dysfunction (BVD) and failure (BVF) as defined by the Valve Academic Research Consortium (VARC)-3 Criteria.(30 days)
- Echocardiographic assessment of prosthetic valve performance(30 days)
- Change in NYHA class from Baseline(30 days)
- Rehospitalization for cardiovascular causes(30 days)
- Myocardial infarction (adapted from 4th Universal, SCAI, and ARC-2 definitions)(30 days)
- All-cause mortality(30 days)
- Stroke(30 days)
- Cardiovascular mortality(30 days)
- VARC-3 bleeding(30 days)
- Vascular and access-related complications(30 days)
- Cardiac structural complications(30 days)
- Other acute procedural and technical valve-related complications(30 days)
- Conduction disturbance requiring permanent pacemaker implantation(30 days)
- Acute kidney injury(30 days)
- Change in Quality of life (KCCQ) from Baseline(30 days)
- Technical Success(30 days)
- Device Success (for Redo-TAVR)(30 days)
- Safety Composite Endpoints(30 days)
研究者
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