Left Atrial Anatomy Reconstruction Using Model Based Fast Anatomical Mapping
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- mMap Scoring Questionnaire
研究概览
简要总结
This prospective, multicenter observational study will examine the ability of model based fast anatomical mapping (mFAM) to create left atrial (LA) geometry for atrial fibrillation ablation.
详细描述
This prospective, multicenter observational study will examine the ability of model based fast anatomical mapping (mFAM) to create left atrial (LA) geometry for atrial fibrillation ablation.
Specifically, the study will assess the following issues in atrial fibrillation ablation:
- Accuracy of map (defined as the distance between the ablation points and the surface of the mFAM geometry)
- Left atrial geometry creation time
- Fluoroscopy time
The clinical team will hypothesize that this approach will lead to accurate LA geometry creation more rapidly and using less fluoroscopy than standard techniques
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
- 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
- •Age ≥ 18 years
- •Have AF as follows:
- •Paroxysmal AF - defined as AF that is non-sustained (terminate without electrical or pharmacologic cardioversion) lasting < 7 days.
- •Persistent AF - defined as AF that is sustained > 7 days. Episodes of AF which are terminated by electrical or pharmacologic cardioversion after ≥ 48 hours of AF, but prior to 7 days, should also be classified as persistent AF episodes.
- •Are planned to undergo a first catheter ablation procedure (prior typical atrial flutter is allowed)
- •Have the ability to understand the requirements of the study and sign the informed consent form.
- •Are willing to adhere to study restrictions and comply with all post-procedural follow-up requirements
排除标准
- •Rheumatic heart disease,
- •Current intra-cardiac thrombus
- •Class IV HF
- •Unable to sign consent
- •Unstable angina
- •Recent cerebral ischemic events
- •Contradiction to anticoagulation
- •Prior cardiac surgery
- •Complex congenital heart disease
结局指标
主要结局
mMap Scoring Questionnaire
时间窗: hospital discharge, average 24 hours post procedure
mMap Scoring Questionnaire: Tool used by operators to rate the accuracy of the map based on the distance between ablation points and accuracy of anatomy compared to the mapped mFam geometry. Total score from 1-7, with lower score indicating not representing (misleading) and higher score indicating agreement (accurate)
次要结局
- Left Atrial Geometry Creation Time(during the procedure up to 60 minutes)
- Fluoroscopy Time(hospital discharge, average 24 hours post procedure)
研究者
Vivek Reddy
Professor
Icahn School of Medicine at Mount Sinai