Radiofrequency Energy Applications Targeting Significant Residual Leaks After Left Atrial Appendage Occlusion
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Procedural Success
研究概览
简要总结
Although the clinical impact of residual left atrial appendage (LAA) leaks still requires confirmation, its patency resulting from incomplete LAA closure may promote blood stagnation and thrombus formation, and increase the risk of thromboembolic events. The main purpose of this trial is to evaluate the safety and efficacy of percutaneous leak closure with radiofrequency energy applications.
详细描述
Therapies locally targeting the LAA via occlusion, exclusion, or excision have emerged as an alternative and effective approach for stroke prophylaxis in AF patients, especially those with OAC contra-indications. Despite mounting evidence of their safety and efficacy in comparison with standard oral therapy, device-related thrombus and incomplete LAA closure resulting in residual, significant leak may occur, potentially hindering an effective stroke prevention. Radiofrequency energy has been adopted in several settings (e.g., vascular, orthopedic, aesthetic surgery) to achieve thermal-induced tissue retraction.
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.
- •Presence of a significant LAA leak acutely or at follow-up.
- •Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
排除标准
- •Life expectancy < 2 years.
- •pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- •presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
结局指标
主要结局
Procedural Success
时间窗: 1-3 months
Complete LAA occlusion or presence of a mild/minimal peri-device leak on FU TEE
次要结局
- Peri-Procedural Success(Peri-Procedural)
研究者
Andrea Natale
Executive Medical Director
Texas Cardiac Arrhythmia Research Foundation