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The design of this study is an intervention, randomized, controlled study and contains three randomized groups:(1)PVI group;(2)PVI+PWI group;(3)PVI+PWI+EGM group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVI group | Sham Comparator | PVI |
|
| PVI+ PWI group | Experimental | PVI+ PWI |
|
| PVI+ PWI+EGM group | Experimental | PVI+ PWI+EGM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVI | Procedure | PVI |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from any documented atrial arrhythmia - atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - of more than 30 seconds, excluding the initial 3 months blanking period, at a minimum of 12 months follow up after a single ablat | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from AF after a single procedure without anti-arrhythmic medications (excludes the blanking period) at 12 months | 12 months | |
| Freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mu Qin | Contact | 13052320103 | qinmuae@163.com | |
| Xumin Hou | Contact | houxumin@shchest.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | 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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| PWI |
| Procedure |
PWI |
|
| EGM | Procedure | EGM |
|
| 12 months |
| The atrial fibrillation burden among study groups at 12-month follow-up (excluding the initial 3-month blanking period) after 1 to 2 ablation procedures, with or without discontinuation of antiarrhythmic drugs. | 12 months |
| Freedom from any documented atrial arrhythmia episodes lasting >30 seconds at 12-month follow-up (excluding the initial 3-month blanking period) after 1 to 2 ablation procedures, with or without discontinuation of antiarrhythmic drugs (AADs) | 12 months |
| Freedom from any documented sustained atrial arrhythmia episodes lasting >7 days at 12-month follow-up (excluding the initial 3-month blanking period) after 1 to 2 ablation procedures, with or without antiarrhythmic drug therapy | 12 months |
| freedom from any documented symptomatic atrial fibrillation/flutter/tachycardia episodes (>30 seconds) after assessment of all ablation procedures at final follow-up, excluding the initial 3-month blanking period. | 12 months |
| Procedure time / Fluoroscopy time / ablation time | 12 months |
| Periprocedural complications, including stroke, pulmonary vein stenosis, cardiac perforation, esophageal injury, and mortality. | 12 months |
| Quality of life assessments during ≥12-month follow-up (AFEQT) | 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |