Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open label, randomized parallel control clinical trial evaluating the efficacy and safety of catheter ablation and surgical ablation 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 the group A (circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation), group B (circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion) and group C (surgical ablation). Postoperative recurrence rate and other indicators are analyzed to evaluate the efficacy and safety of catheter ablation and surgical ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.
Not provided
Not provided
Not provided
Not provided
| 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 + vein of Marshall ethanol infusion |
|
| Group C | Active Comparator | Surgical ablation |
|
| 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 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 12 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 |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mu Qin, M.D. | Contact | +8613052320103 | qinmuae@163.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| Surgical ablation | Procedure | Patients receive surgical ablation. |
|
| up to 12 months after enrollment |
| Incidence of complications | death, atrioesophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, diaphragmatic paralysis, pneumothorax, pleural effusion, heart block, pulmonary vein stenosis, pulmonary edema, pericarditis and major vascular access complication or bleeding | up to 12 months after enrollment |
| Changes in the diameter of the left atrium and the left ventricular ejection fraction | Changes in the diameter of the left atrium and the left ventricular ejection fraction | up to 12 months after enrollment |
| 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 |
Not provided
Not provided