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This is a single-arm clinical trial evaluating the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.
This is a single-arm clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are enrolled as subjects to conduct left atrial isolation by catheter ablation. Postoperative recurrence rate and other indicators are analyzed to evaluate the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left atrial isolation arm | Experimental | All the enrolled subjects will receive left atrial isolation through catheter ablation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left atrial isolation by catheter ablation | Procedure | Procedure: Right pulmonary vein circumferential isolation + anterior left atrial line (superior mitral annulus to right superior pulmonary vein via the anterior wall) + para-septal line (para-septal mitral annulus to the right inferior pulmonary vein, including right atrial components-especially in and around the proximal coronary sinus) + posterior left atrial line (superior mitral annulus to right superior pulmonary vein via the posterior wall). |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate | AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration | up to 18 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative AF recurrence rate | AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration | up to 18 months after enrollment |
| Postoperative AFL/AT rate | Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mu Qin, M.D. | Contact | +8613052320103 | qinmuae@163.com |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| up to 18 months after enrollment |
| Incidence of complications | including death, atrio-esophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, diaphragmatic paralysis, pneumothorax, pleural effusion, heart block, pulmonary vein stenosis, pulmonary edema, left atrial thrombus, pericarditis and major vascular access complication or bleeding | up to 18 months after enrollment |
| Changes in the diameter of the left atrium and the left ventricular ejection fraction | up to 18 months after enrollment |
| D013568 |
| Pathological Conditions, Signs and Symptoms |