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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT group | Experimental | CT-Guided Size Selection for LAA Occluder |
|
| DSA group | Active Comparator | DSA-Guided Size Selection for LAA Occluder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT group | Other | After completing the AF ablation, select the appropriate LAA occluder based on preoperative CT measurements for implantation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure success | Technical success of the LAA occlusion procedure without serious procedure-related complications | During procedure |
| Peri-device leak at 3 months post-procedure | Proportion of peri-device leak at the occluder evaluated by TEE or CT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhongbo Xiao, MD | Contact | 307523577@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foshan Nanhai District People's Hospital | Not yet recruiting | Foshan | Guangdong | China |
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| DSA group | Other | After completing the AF ablation, select the appropriate LAA occluder based on intraoperative DSA measurements for implantation. |
|
| 3 months |
| Procedure-related times | Total procedure time, AF ablation time, and LAA occlusion time | 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 | 3 months |
| The Second People's Hospital of Foshan | Not yet recruiting | Foshan | Guangdong | China |
|
| Meizhou Hospital of Traditional Chinese Medicine | Not yet recruiting | Meizhou | Guangdong | China |
|
| First Affiliated Hospital of Shantou University Medical College | Recruiting | Shantou | Guangdong | China |
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| Guangdong Provincial Zhongshan Hospital of Traditional Chinese Medicine | Not yet recruiting | Zhongshan | Guangdong | China |
|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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