NCT05737264招募中不适用
Safety and Effectiveness of Transcatheter Treatment of Severe Native Aortic Regurgitation With Self-Expandable Valve Implantation: a Multicenter, Observational,Cohort Study(SENSE-AR)
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2022年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Disabling stroke
研究概览
简要总结
The study aimed to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in patients with severe native valve aortic insufficiency. It is a multicentre, observational cohort study. The primary endpoint consisted of a composite of all-cause death, disabling stroke, or rehospitalization for heart failure at 12 months postoperatively. According to previous research results and opinions of expert groups, the sample size was expected to be 76 cases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years;
- •Patients with severe aortic regurgitation (> grade 3) diagnosed by transthoracic echocardiography should meet any of the following conditions for semi-quantitative assessment of the degree of aortic regurgitation and any condition for quantitative assessment of the degree of aortic regurgitation: (1) semi-quantitative assessment of the degree of aortic regurgitation: aortic regurgitation bundle width/left ventricular outflow tract diameter ≥ 65%; or aortic regurgitation neck width > 6 mm; or full-diastolic blood flow reflux in the proximal abdominal aorta; (2) quantitative assessment of the degree of aortic regurgitation: aortic regurgitation volume ≥ 60 ml/beat; or aortic regurgitation fraction ≥ 50%; or effective regurgitation orifice area ≥ 0.3 cm2
- •TAVR has been performed;
- •Patients can understand and voluntarily participate in this clinical study, sign informed consent, and adhere to clinical follow-up.
排除标准
- •History of aortic valve replacement;
- •Combined with moderate-severe mitral regurgitation and moderate aortic stenosis;
- •Acute endocarditis or other acute cardiac inflammation;
- •Allergic or contraindicated to related drugs (aspirin, clopidogrel, warfarin, contrast agent);
- •Other conditions judged by the investigator as not suitable for the study
结局指标
主要结局
Disabling stroke
时间窗: 12 months
Stroke that results in a disabled state
Rehospitalization for heart failure
时间窗: 12 months
Rehospitalization for heart failure
all-cause mortality
时间窗: 12 months
Death caused by any reason
次要结局
- Perioperative complications(up to 1 week)
- New permanent pacemaker implantation(PPI)(up to 1 week)
- New complete left bundle branch block(CLBBB)(up to 1 week)
- NYHA class Ill or IV(12 months)
- Device success(intraoperative)
- Valve-related dysfunction(12 months)
研究者
研究点 (1)
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