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
- 2
- 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 (2)
Loading locations...
相似试验
已完成
4 期
Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation Compared to Medical TherapyAtrial FibrillationNCT03463317Charite University, Berlin, Germany912
尚未招募
不适用
The Left Atrial Appendage Closure by Surgery and the Incidence of Stroke in Patients Undergoing Open-heart Surgery.Left Atrial Appendage ThrombosisNCT06172738Assiut University100
已完成
不适用
Left Atrial Appendage Closure With the LAmbreLeft Atrial Appendage ClosureStrokeAtrial FibrillationNCT03147391Shanghai 10th People's Hospital66
撤回
不适用
Effects of Left Atrial Appendage OcclusionAtrial FibrillationNCT00510900University of Pittsburgh
招募中
不适用
The Impact of Atrial Pressure Change Before and After Combined ProcedureHeart FailureAtrial FibrillationNCT05106270Shanghai 10th People's Hospital100