Bicuspid Aortic Valve Replacement: EvaLuatIon of transcathetEr Versus surgEry-PILOT Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- 1 year hierarchical composite outcome of death, disabling stroke, non-disabling stroke, valve reintervention, rehospitalization, unfavorable KCCQ (VARC 3)
研究概览
简要总结
The study protocol is a randomized trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV). Namely, the therapies to which patients will be randomized will be transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR), in patients deemed clinically suitable for both following heart team review.
The purpose of this study is to compare the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) versus Surgical Aortic Valve Replacement (SAVR) for treating patients with severe aortic stenosis (AS) who have a congenital bicuspid aortic valve (BAV) anatomy. Patients with BAV anatomy have been under-represented in previous trials and this study might provide important information to help guide future treatment options.
The study patients will be followed with standard of care procedures for 10 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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged > 50 years of age
- •Site-determined severe AS deemed necessary for treatment with SAVR or TAVR
- •Gated contrast CT available and suitable for core laboratory analysis
- •BAV anatomy confirmed by CT core laboratory analysis
排除标准
- •Recent cardiovascular intervention within the prior 30 days.
- •Presence of an existing TAVR or SAVR device
- •Pregnancy or lactation
- •Extreme or prohibitive TAVR or SAVR risk, determined by site or committee Active enrollment in another investigational study
- •Disproportionate TAVR vs SAVR risk, as determined by treating site or committee
- •Associated aortopathy (AA≥ 45 mm by maximal cross-sectional dimension, as confirmed by CT core laboratory analysis, or AA<45 mm but site plan for surgery of the aorta in the event of randomization to surgery
- •Site plan for treatment of concomitant non-coronary cardiovascular disease in the event of randomization to surgery (for instance, concomitant valve surgery, septal defect or coarctation repair, aorta or root replacement or repair)
- •In the presence of coronary artery disease deemed necessary for revascularization in the event of randomization to SAVR or TAVR, Syntax score ≥ 32 or deemed unsuitable for PCI, or deemed unsuitable for coronary artery bypass grafting (CABG).
研究组 & 干预措施
transcatheter aortic valve replacement (TAVR)
50% of patients will be treated with standard TAVR procedure and followed up for 10 years
干预措施: transcatheter aortic valve replacement (TAVR) (Procedure)
surgical aortic valve replacement (SAVR)
50% of patients will be treated with standard SAVR procedure and followed up for 10 years
干预措施: surgical aortic valve replacement (SAVR) (Procedure)
结局指标
主要结局
1 year hierarchical composite outcome of death, disabling stroke, non-disabling stroke, valve reintervention, rehospitalization, unfavorable KCCQ (VARC 3)
时间窗: 1 year
The primary endpoint will be analyzed by the Win ratio method14. That is, every patient in the TAVR group will be compared with every patient in the SAVR group to determine which pair has won. A win higher up in the hierarchy takes priority, so KCCQ gets used only for those pairs that were tied on the first 5 event components. Then KCCQ win is declared if the time-averaged change in KCCQ differs by 5 points or more. The win ratio= total wins on TAVR divided by total wins on SAVR, for which a 95% CI and p value is calculated.
次要结局
- Technical success at time of exit from OR/cath lab(exit from procedure (OR or cath lab))
- Device success(30 days)
- Procedural success(30 Days)
- Patient success(1 year)
研究者
Raj Makkar
MD
Cedars-Sinai Medical Center