Transcatheter Aortic Valve Replacement With Pure Echocardiography Guidance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Valve Academic Research Consortium-3
研究概览
简要总结
This study aims to evaluate the safety and feasibility of performing transaxillary transcatheter aortic valve replacement (TA TAVR) guided solely by echocardiography in patients with severe aortic stenosis (AS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •symptomatic severe AS determined by echocardiography and Doppler that requiring aortic valve replacement, defined as: mean gradient ≥40 mmHg, peak aortic velocity ≥4 m/s, and aortic valve area (AVA) ≤1 cm2 (or an indexed AVA ≤0.6 cm2/m2)
- •a history of malignancy or a high familial risk of cancer, with refusal to undergo contrast- or radiation-guided procedures
- •chronic kidney disease and refuse to receive contrast agents or radiation exposure.
- •suitable for Transaxillary TAVR
排除标准
- •required hybrid procedures or concomitant interventions on other cardiac malformations
- •inoperable due to extremely high surgical risk or severe comorbidities
- •untreated clinically significant (>70% obstruction) proximal vessel coronary vascular disease amenable to revascularization
- •previously undergone aortic valve replacement.
研究组 & 干预措施
Echo guided TAVR
Patients received Echocardiography guided TAVR
干预措施: Echocardiography guided TAVR (Procedure)
结局指标
主要结局
Valve Academic Research Consortium-3
时间窗: 30 days after intervention
Outcomes were reported according to the VARC-3 criteria.Which include: Technical success: Evaluated immediately post-procedure (e.g., successful vascular access, device delivery, deployment, no immediate complications). Device success: Includes successful valve function with acceptable hemodynamics and positioning. Procedural success: Includes 30-day outcomes, combining technical/device success and absence of major complications.
次要结局
未报告次要终点
研究者
Pan Xiangbin
Principle Investigator
Chinese Academy of Medical Sciences, Fuwai Hospital