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| Name | Class |
|---|---|
| Albert Einstein College of Medicine and Montefiore Medical Center | UNKNOWN |
| Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine | UNKNOWN |
| Shandong University of Traditional Chinese Medicine |
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This multicenter, randomized controlled trial aims to compare the efficacy and safety of extensive electro-anatomical guided pulsed field ablation (EXT-PFA) with traditional radiofrequency ablation (RF) in treating persistent atrial fibrillation (PeAF). The trial seeks to determine if EXT-PFA, which integrates anatomical and electrogram-guided strategies, can provide superior outcomes in terms of safety and effectiveness compared to the standard RF ablation approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed field ablation | Experimental | Utilizing pulsed field ablation (PFA), combining pulmonary vein isolation (PVI) with extensive ablation based on anatomical landmarks (including posterior wall box isolation) and electrogram-guided ablation, aiming to target all potential arrhythmic substrates. |
|
| Radiofrequency Ablation | Active Comparator | Using conventional radiofrequency ablation technology, combines pulmonary vein isolation (PVI) with extensive ablation based on anatomical landmarks (including posterior wall box isolation) and electrogram-guided ablation, aiming to target all potential arrhythmic substrates. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed field ablation | Procedure | Utilizing pulsed field ablation (PFA), combining pulmonary vein isolation (PVI) with extensive ablation based on anatomical landmarks (including posterior wall box isolation) and electrogram-guided ablation. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from Atrial Arrhythmia Recurrence at 12 Months | Proportion of participants free from atrial fibrillation/atrial flutter/atrial tachycardia recurrence at 12 months post-ablation. | 12 months after ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Safety | Incidence of procedural complications such as esophageal injury and pulmonary vein stenosis. | From enrollment to completion of follow-up（at least 12 months） |
| Symptom Relief (EHRA scores) |
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Inclusion Criteria:
1.Adults aged 18-80 years diagnosed with persistent atrial fibrillation. 2.Ineffectiveness or intolerance to at least one Class I or III anti-arrhythmic drug.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Liu, MD | Contact | +86 021-22200000 | drliuxu@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xu Liu | Shanghai Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No. 241, West Huaihai Road | Shanghai | Shanghai Municipality | 200000 | China |
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| Yuhuan Second People's Hospital | UNKNOWN |
| Changshu Hospital of Traditional Chinese Medicine | OTHER |
| The PLA Navy Anqing Hospital | UNKNOWN |
| Jinan People's Hospital | UNKNOWN |
| Xuzhou Central Hospital | OTHER |
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| Radiofrequency ablation alone | Procedure | Using conventional radiofrequency ablation technology, combines pulmonary vein isolation (PVI) with extensive ablation based on anatomical landmarks (including posterior wall box isolation) and electrogram-guided ablation |
|
Improvement in clinical symptoms (EHRA scores)
| From enrollment to completion of follow-up（at least 12 months） |
| Quality of Life (Short Form 36 Health Survey). | quality of life measurements (Short Form 36 Health Survey). | From enrollment to completion of follow-up（at least 12 months） |
| Atrial Fibrillation Burden Reduction | Reduction in atrial fibrillation burden assessed through follow-up evaluations. | From enrollment to completion of follow-up（at least 12 months） |
| 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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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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