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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
238
Foshan Nanhai District People's Hospital
Foshan, Guangdong, China
NOT_YET_RECRUITINGThe Second People's Hospital of Foshan
Foshan, Guangdong, China
NOT_YET_RECRUITINGMeizhou Hospital of Traditional Chinese Medicine
Meizhou, Guangdong, China
NOT_YET_RECRUITINGFirst Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
RECRUITINGGuangdong Provincial Zhongshan Hospital of Traditional Chinese Medicine
Zhongshan, Guangdong, China
NOT_YET_RECRUITINGAccuracy 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.
Time frame: During procedure
Procedure success
Technical success of the LAA occlusion procedure without serious procedure-related complications
Time frame: During procedure
Peri-device leak at 3 months post-procedure
Proportion of peri-device leak at the occluder evaluated by TEE or CT
Time frame: 3 months
Procedure-related times
Total procedure time, AF ablation time, and LAA occlusion time
Time frame: During procedure
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
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.