Transcatheter Aortic Valve Replacement With 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 (VARC-3)
研究概览
简要总结
Conventional transcatheter aortic valve replacement (TAVR) relies on fluoroscopic and contrast agents. However, in high-risk patients, exposure to ionizing radiation and contrast agents is contraindicated and undesirable. Echocardiography guidance TAVR can offer a feasible and safer strategy for TAVR.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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, which is 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.
排除标准
- •Required hybrid procedures or concomitant interventions on other cardiac malformations; Deemed inoperable due to extremely high surgical risk or severe comorbidities; Had untreated clinically significant coronary vascular disease amenable to revascularization; Previously undergone aortic valve replacement.
结局指标
主要结局
Valve Academic Research Consortium-3 (VARC-3)
时间窗: 30-day after surgery
VARC3 include but not limited to Mortality (all-cause and cardiovascular) Stroke and transient ischemic attack (TIA) Acute kidney injury Conduction disturbances and permanent pacemaker implantation Bleeding (updated using BARC criteria) Myocardial infarction Vascular access complications Endocarditis
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