REpeat Intervention for Failed Surgical BioProsthEtic AorTic Valves (REPEAT): A Multicenter Randomized Trial Comparing Redo Surgical Aortic Valve Replacement to Valve-in-Valve Transcatheter Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 890
- 试验地点
- 1
- 主要终点
- The primary endpoint will be a composite endpoint including all-cause mortality, all-cause stroke, myocardial infarction, and re-hospitalization for heart failure or aortic valve reintervention at 5 years.
研究概览
简要总结
The overall hypothesis is that redo aortic valve replacement (rAVR) is superior to valve-invalve transcatheter aortic valve replacement (ViV-TAVR) for the composite endpoint of freedom from all-cause mortality, all-cause stroke, myocardial infarction, and rehospitalization for heart failure or aortic valve re-intervention at 5 years.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for repeat intervention for failed surgical aortic bioprosthesis due to structural valve deterioration (SVD; prosthesis stenosis and/or transprosthetic insufficiency);
- •Low to intermediate surgical risk (i.e., Society of Thoracic Surgeons (STS) predicted risk of mortality of < 8%);
- •Age > 18 and < 75 years;
- •Both rAVR and ViV-TAVR are judged to be reasonable options based on evaluation by the local Heart Team
排除标准
- •Multiple valvular disease requiring surgical intervention;
- •High-risk coronary anatomy resulting in increased risk of coronary obstruction following ViV-TAVR prosthesis deployment;
- •Complex coronary artery disease requiring revascularization (unprotected left main coronary artery, Syntax score > 32) and Heart Team assessment that optimal revascularization cannot be performed;
- •Failing valve with evidence of bacterial endocarditis or evidence of non-structural valve deterioration (e.g., paravalvular leak, thrombosis);
- •Increased post-procedural gradients (mean > 20 mmHg) or severe patient-prosthesis mismatch (PPM, indexed effective orifice area < 0.65 cm2/m2) at discharge from index aortic valve replacement (AVR) procedure;
- •Patients who choose to receive a mechanical AVR.
研究组 & 干预措施
ViV-TAVR
The intervention under investigation is transcatheter - preferably transfemoral - ViV-TAVR applied for degenerated surgical aortic bioprostheses with an indication for re-intervention in patients at low-to-intermediate surgical risk. An aortic transcatheter bioprosthesis is implanted into the degenerated surgical aortic bioprosthesis.
干预措施: Transfemoral transcatheter valve-in-valve implantation (Procedure)
redoAVR
Surgical redoAVR serves as the control intervention. The patient's degenerated aortic bioprosthesis is replaced using conventional open-heart surgery.
干预措施: Surgical redo aortic valve replacement (Procedure)
结局指标
主要结局
The primary endpoint will be a composite endpoint including all-cause mortality, all-cause stroke, myocardial infarction, and re-hospitalization for heart failure or aortic valve reintervention at 5 years.
时间窗: 5 years
based on VARC-3
次要结局
- Each of the individual components of the primary composite endpoint(5 years)
- Valve Academic Research Consortium-3 (VARC-3)1-based conduction disturbances and arrhythmia(5 years)
- Wound and bleeding complications (based on Bleeding Academic Research Consortium class 3b-5)(5 years)
- New York Heart Association classification III or IV(5 years)
- Health status evaluated by the Kansas City Cardiomyopathy Questionnaire(5 years)
- Health status evaluated by the SF-36 questionnaire(5 years)
- Six-minute walk test(5 years)
- Treatment Costs per quality adjusted life year Assessment of Safety(5 years)