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This is an open label, multi-center, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation.
This is an open label, multi-center, randomized parallel control clinical trial. Patients with persistent atrial fibrillation are 1:1 randomized into the experimental group (driver ablation+ circumferential pulmonary vein isolation) or the control group (stepwise ablation). Postoperative atrial fibrillation recurrence rate and other indicators are analyzed to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Driver ablation+CPVI | Experimental | Driver ablation plus CPVI (circumferential pulmonary vein isolation) |
|
| Stepwise ablation | Active Comparator | Stepwise ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Driver ablation+CPVI | Procedure | Patients receive driver ablation and CPVI (circumferential pulmonary vein isolation). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative atrial fibrillation (AF) recurrence rate | AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration. | up to 24 months after enrollment |
| Procedural AF termination rate | AF termination is defined as conversion to sinus rhythm or a stable atrial flutter (AFL)/atrial tachycardia (AT). | Before the end of procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative atrial flutter (AFL) or atrial tachycardia (AT) rate | Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration. | up to 24 months after enrollment |
| Incidence of complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | China |
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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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| Stepwise ablation | Procedure | Patients receive stepwise ablation. |
|
Complications include: death, atrioesophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, transient ischemic attack (TIA), diaphragmatic paralysis, pneumothorax, heart block, pulmonary vein stenosis, pulmonary edema, pericarditis, and major vascular access complication or bleeding.
| up to 2 weeks after enrollment |
| D013568 |
| Pathological Conditions, Signs and Symptoms |