CompariSon of secOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in Transcatheter Aortic Valve Implantation (SOLVE-TAVI)
试验速览
- 阶段
- 不适用
- 入组人数
- 444
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (Anesthesia)
研究概览
简要总结
Aim of the study is to demonstrate equivalence of second-generation self-expandable valves (CoreValve Evolut R) in comparison to second-generation balloon-expandable valves (Edwards Sapien 3) and of local anesthesia with conscious sedation in comparison to general anesthesia with respect to safety and efficacy in high-risk patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe symptomatic aortic valve stenosis defined as aortic valve area (AVA) ≤ 1cm2 or 0.6 cm²/m²
- •Age ≥75 years and/or logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) ≥20% and/or Society of Thoracic Surgeons (STS) risk score ≥10% and/or high risk/contraindication to conventional surgical aortic valve replacement
- •Native aortic valve annulus measuring 18-29 mm
- •Suitability for transfemoral vascular access
- •Written informed consent
排除标准
- •Life expectancy <12 months due to comorbidities
- •Cardiogenic shock or hemodynamic instability
- •History of or active endocarditis
- •Contraindications for transfemoral access
- •Active peptic ulcer or upper gastro-intestinal bleeding <3 months
- •Hypersensitivity or contraindication to aspirin, heparin or clopidogrel
- •Contraindication for a specific mode of anesthesia as judged by the cardiac anesthesia representative of the Heart Team
- •Active infection requiring antibiotic treatment
- •Participation in another trial
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (Anesthesia)
时间窗: 30 day follow-up
Number of participants with adverse events related to the treatment at 30-day follow-up consisting of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury
Incidence of Treatment-Emergent Adverse Events (Device)
时间窗: 30 day follow-up
Number of participants with adverse events related to the treatment at 30-day follow-up consisting of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation
次要结局
未报告次要终点
研究者
Holger Thiele, MD
Director
Heart Center Leipzig - University Hospital