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The study is designed as a randomized control trial. The purpose of this study is to observe the efficacy and safety of atrial fibrillation ablation, comparing circumferential pulmonary vein isolation (CPVI) plus renal sympathetic modification (RSM) with CPVI alone.
Basic studies suggested that sympathetic nerves over-activity played an important role in the pathophysiological changes of arrhythmia occurrence. Present studies of renal ablation show a new method to decrease sympathetic nerves activity. Circumferential pulmonary vein isolation (CPVI) is an accepted ablation method for atrial fibrillation. The investigators plan to evaluate the efficiency and safety of CPVI plus renal sympathetic modification for atrial fibrillation ablation comparing with CPVI alone. The trial is going to recruit 100 patients randomized into two groups (CPVI+RSM group VS CPVI group = 50:50) with a follow-up duration of 4 years. The investigators aim to observe the relapse of atrial tachyarrhythmia lasting more than 30 seconds, the incidence of composite cardiovascular events after renal sympathetic modification, and safety and efficacy of the intervention, comparing with CPVI alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPVI+RSM group | Experimental | Circumferential pulmonary vein isolation (CPVI) plus renal sympathetic modification for atrial fibrillation ablation. |
|
| CPVI group | Active Comparator | Circumferential pulmonary vein isolation is done alone for atrial fibrillation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPVI plus renal sympathetic modification | Procedure | CPVI plus renal denervation to reduce atrial arrhythmia recurrence. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The relapse rate of atrial tachyarrhythmia | Atrial tachyarrhythmia lasting more than 30 seconds consider relapsed | Four years |
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Inclusion Criteria:
• ≥ 18 years old, and ≤ 75 years old of age
Exclusion Criteria:
• transesophageal echocardiography found thrombus in left atrial appendage
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuehui Yin, MD | Contact | 0086-13508335502 | yinyh63@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2ndChongqingMU | Recruiting | Chongqing | Chongqing Municipality | 400010 | 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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| CPVI | Procedure | CPVI alone to reduce atrial arrhythmia recurrence. |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |