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| Name | Class |
|---|---|
| Shandong University of Traditional Chinese Medicine | OTHER |
| Department of Cardiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine | UNKNOWN |
| Wuhan Central Hospital | OTHER |
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This is a randomized control trial to compare the efficacy and safety of CARTO-Finder-guided ablation plus pulmonary vein isolation versus multiscale entropy (MSE)-guided pulmonary vein isolation in patients with persistent atrial fibrillation.
This is a randomized control trial. Patients with persistent atrial fibrillation are enrolled and randomized to CARTO-Finder-guided ablation plus PVI group or MSE-guided ablation plus PVI group. Postoperative recurrence rate and other indicators are analyzed to compare the efficacy and safety between CARTO-Finder-guided ablation plus PVI and MSE-guided ablation plus PVI in patients with persistent atrial fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CARTO-Finder-guided ablation plus PVI | Active Comparator | Pulmonary vein circumferential isolation + + ablation of sites recognized by CARTO-Finder module as the core of rotors. |
|
| Multiscale entropy-guided ablation plus PVI | Experimental | Pulmonary vein circumferential isolation + ablation of sites recognized by multiscale entropy analysis as the core of rotors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiscale entropy-guided ablation plus PVI | Procedure | The multiscale entropy is calculated based on intracardiac electrical signals, higher multiscale entropy value indicates closer to the core of rotors which maintains the persistent atrial fibrillation. |
| 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 24 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 24 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the diameter of the left atrium | Changes in the diameter of the left atrium | up to 24 months after enrollment |
| Changes in the diameter of the left ventricular ejection fraction | Changes in the diameter of the left ventricular ejection fraction |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Liu, M.D. | Contact | 18017321689 | heartlx@sina.com |
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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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| Affiliated Hospital of Jining Medical University | OTHER |
| Department of Cardiology, Yuhuan Second People's Hospital | UNKNOWN |
| Department of Cardiology, Changshu Hospital of Traditional Chinese Medicine | UNKNOWN |
| Department of Cardiology, The PLA Navy Anqing Hospital | UNKNOWN |
| Department of Cardiology, Jinan City People's Hospital | UNKNOWN |
| Department of Cardiology, Xuzhou Central Hospital | UNKNOWN |
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| CARTO-Finder-guided ablation plus PVI | Procedure | CARTO-Finder-guided ablation plus PVI |
|
| up to 24 months after enrollment |
| up to 24 months after enrollment |
| Incidence of complications | 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 24 months after enrollment |
| D013568 |
| Pathological Conditions, Signs and Symptoms |