The Accuracy of Left Atrial Appendage Occluder Size Selection Between Preoperative CT and Intraoperative DSA Evaluation During a Combined Atrial Fibrillation Ablation and Left Atrial Appendage Occlusion Procedure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 238
- 试验地点
- 5
- 主要终点
- Accuracy of LAA occluder size selection
研究概览
简要总结
This study is a prospective, multi-center, randomized controlled trial. The subjects are patients scheduled to undergo a combined procedure of atrial fibrillation (AF) ablation and left atrial appendage (LAA) occlusion. After signing the informed consent form, the subjects will be randomly assigned to either the cardiac Computed Tomography (CT) group or the Digital Subtraction Angiography (DSA) group. The operator will select the appropriate LAA occluder size for implantation based on different measurement methods. All subjects will undergo clinical follow-up before discharge and at 3 months postoperatively, as well as telephone follow-up 1-5 years after the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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;
- •Patients with non-valvular atrial fibrillation scheduled to undergo atrial fibrillation ablation and percutaneous left atrial appendage occlusion;
- •Able to understand the purpose of the trial, willing to participate in the study, and the subject or their legal representative has signed the informed consent form, and is willing to complete the follow-up according to the protocol requirements.
排除标准
- •Allergy to contrast agents or other conditions that preclude cardiac CT or DSA imaging;
- •Absence of clear images for measuring the diameter of the LAA in all layers of the CT scan;
- •Imaging indicates the presence of thrombus in the left atrium or LAA;
- •Patients with valvular AF (mechanical valve replacement or moderate to severe mitral stenosis combined with AF);
- •LAA depth < 15 mm, or LAA anchor zone diameter < 10 mm or > 33 mm;
- •Female patients of childbearing age planning to become pregnant during the follow-up period required by this study;
- •Currently participating in another clinical trial of drugs or medical devices and has not yet completed the primary endpoints of that study, which may confound the results of this study or affect the participant's compliance with the follow-up;
- •Other conditions that the investigator deems make the participant unsuitable for this study.
结局指标
主要结局
Accuracy of LAA occluder size selection
时间窗: During procedure
Accuracy is defined as: the occluder's anchor disc seats beyond the circumflex artery, the compression of the anchor disc after release is 3-6 mm, peri-device leak is ≤ 3 mm, and the occluder remains stable during the tug test.
次要结局
- Procedure success(During procedure)
- Peri-device leak at 3 months post-procedure(3 months)
- Procedure-related times(During procedure)
- Incidence of major adverse events (MAE) related to the device or procedure within 3 months post-procedure(3 months)
研究者
Zhongbo Xiao
Chief physician
First Affiliated Hospital of Shantou University Medical College