NCT05150366已完成不适用
Impact of Percutaneous Closure of the Left Atrial on the Maximum Proto-diastolic Speed of the Mitral Ring Measured by Tissue Doppler
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- lateral e' speed
研究概览
简要总结
The main objective is to demonstrate the equivalence, before and after the percutaneous closure of the left atrial procedure, of the maximum proto-diastolic velocity of the lateral mitral annulus (e 'lat) measured by tissue Doppler. Patients with AF at high embolic risk and presenting a formal and definitive contraindication to anticoagulants having been operated on for percutaneous closure of the left atrial by St Jude AMULET device, considering an equivalence margin of 1 cm / sec.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman over 18 years-old
- •Patient with paroxysmal AF at high embolic risk (CHA2DS2Vasc score ≥ 4) and presenting a formal and definitive contraindication to anticoagulants
- •Patient scheduled for percutaneous closure of the left auricle by St Jude AMULET device
- •Patient in sinus rhythm
- •Subject affiliated or beneficiary of a social security scheme
- •Patient having signed the informed consent
排除标准
- •Patient participating in another clinical study
- •Patient in permanent ACFA
- •Patient with a mitral prosthesis (biological or mechanical),
- •Patient with a history of mitral annuloplasty
- •Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision;
- •Pregnant, breastfeeding or parturient woman;
- •Patient hospitalized without consent.
研究组 & 干预措施
Patient scheduled for percutaneous closure of the left auricle by St Jude AMULET device
Experimental
干预措施: Trans thoracic echocardiography (Procedure)
结局指标
主要结局
lateral e' speed
时间窗: 1 day
measured by tissue Doppler
次要结局
未报告次要终点
研究者
研究点 (1)
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