CPVI Plus Renal Sympathetic Modification Versus CPVI Alone for AF（Atrial Fibrillation） Ablation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Circumferential Pulmonary Vein Isolation (CPVI) Plus Renal Sympathetic Modification Versus CPVI Alone for AF Ablation: a Pilot Study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: CPVI plus renal sympathetic modification
* Procedure: CPVI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • ≥ 18 years old, and ≤ 75 years old of age more than half a year history of atrial fibrillation, no matter paroxysmal or persistent, with clinical symptom or ECG proved be ineffective to at least one kind of anti-arrhythmic drugs treatment echocardiography has done to except structural heart diseases such as congenital, valvular heart diseases and kinds of cardiomyopathy estimated glomerular filtration rate (eGFR) of ≥ 45ml/min is competent and willing to provide written, informed consent to participate in this clinical study Exclusion Criteria: • transesophageal echocardiography found thrombus in left atrial appendage past history of atrial fibrillation surgical maze procedure estimated glomerular filtration rate (eGFR) of < 45mL/min has the history of renal restenosis or renal stents implantation has experienced AMI（acute myocardial infarction） (old myocardial infarction is not excluded), unstable angina pectoris, cerebrovascular accidents, and alimentary tract hemorrhage within 3 months patients with sick sinus syndrome pregnant women mental disorders patients that have allergy to contrast agent patients that do not go with follow-up others such as researcher considers it is not appropriate to be included into the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPVI+RSM group<br>Circumferential pulmonary vein isolation (CPVI) plus renal sympathetic modification for atrial fibrillation ablation. | Procedure: CPVI plus renal sympathetic modification<br>* CPVI plus renal denervation to reduce atrial arrhythmia recurrence.<br>* Other names: renal ablation;|
| Active Comparator: CPVI group<br>Circumferential pulmonary vein isolation is done alone for atrial fibrillation. | Procedure: CPVI<br>* CPVI alone to reduce atrial arrhythmia recurrence.<br>* Other names: circumferential pulmonary vein ablation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relapse rate of atrial tachyarrhythmia | Atrial tachyarrhythmia lasting more than 30 seconds consider relapsed | Four years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation