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This is an open label, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation with severe atrial fibrosis.
This is an open label, randomized parallel control clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are 1:1:1 randomized into group A (circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation), group B (circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation) and group C (circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion). Postoperative recurrence rate and other indicators are analyzed to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation with severe atrial fibrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation |
|
| Group B | Active Comparator | Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation |
|
| Group C | Active Comparator | Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation | Procedure | Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with bi-atrial mapping and driver ablation. |
| 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 12 months after ablation |
| Intraoperative AF termination rate | AF termination is defined as conversion to sinus rhythm or stable AFL/AT. | through ablation completion, an average of 3 hours |
| 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 12 months after ablation |
| 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:
12. Presence of an implanted cardioverter-defibrillator; 13. Previous history of cardiac surgery; 14. Poor general health; 15. Life expectancy less than 6 months.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mu Qin, M.D. | Contact | +8613052320103 | qinmuae@163.com |
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|
| Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation | Procedure | Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with posterior wall box isolation. |
|
| Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion | Procedure | Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with vein of Marshall ethanol infusion. |
|
| up to 12 months after ablation |
| Incidence of complications | death, atrioesophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, diaphragmatic paralysis, pneumothorax, heart block, pulmonary vein stenosis, pulmonary edema, pericarditis and major vascular access complication or bleeding | up to 12 months after ablation |
| Changes in the diameter of the left atrium | Changes in the diameter of the left atrium | up to 12 months after ablation |
| Changes in the left ventricular ejection fraction | Changes in the left ventricular ejection fraction | up to 12 months after ablation |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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