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.
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.
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);
Parallel
CT group
Other interventionAfter completing the AF ablation, select the appropriate LAA occluder based on preoperative CT measurements for implantation.
DSA group
Other interventionAfter completing the AF ablation, select the appropriate LAA occluder based on intraoperative DSA measurements for implantation.
Accuracy of LAA occluder size selection
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.
Procedure success
Technical success of the LAA occlusion procedure without serious procedure-related complications
Peri-device leak at 3 months post-procedure
Proportion of peri-device leak at the occluder evaluated by TEE or CT
Procedure-related times
Total procedure time, AF ablation time, and LAA occlusion time
Incidence of major adverse events (MAE) related to the device or procedure within 3 months post-procedure
MAE is defined as unexplained death or any device or procedure-related complications, including but not limited to death, stroke, or transient ischemic attack (TIA), serious pericardial effusion/pericardial tamponade requiring pericardiocentesis or surgery, device embolization, life-threatening or severe bleeding events, and severe vascular access complications
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