Acute Impairment in Left Atrial and Left Atrial Appendage Function Pre- and Post-Pulse Field Ablation Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation: A Prospective Intraprocedural Intracardiac Echocardiography Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. Change in LAA Ev between pre- and post- PFA measurements.
研究概览
简要总结
A prospective study that investigates the changes in LA echocardiographic parameters after PFA for paroxysmal AF.
详细描述
This study will leverage ICE to define the acute effects of PFA-PVI on LA and LAA function. The findings will deliver pivotal insights into the functional safety of PFA, clarifying whether a transient stunning effect exists and informing the evolution of peri-procedural anticoagulation management.
Research Objectives
Primary Objective:
To quantify the acute changes in LAA mechanical function immediately following PVI using PFA in patients with paroxysmal AF, as assessed by intraprocedural ICE.
Secondary Objectives:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Paroxysmal AF in sinus rhythm at procedural onset
排除标准
- •Persistent or long-standing AF
- •Prior atrial ablation
- •Significant valvular disease
- •A history of LAA closure
研究组 & 干预措施
Cohort 1
Measurement of the LA and LAA echocardiographic parameters pre- and post-PFA for paroxysmal AF.
干预措施: LA and LAA function measurements (Diagnostic Test)
结局指标
主要结局
1. Change in LAA Ev between pre- and post- PFA measurements.
时间窗: During the procedure
次要结局
未报告次要终点
研究者
Marek Hozman, MD, PhD
Principal Investigator
Charles University, Czech Republic