The Chinese Registration Study of Driver Ablation of Persistent Atrial Fibrillation.

Study Overview
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Brief Summary
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This is an open label, multi-center, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation.

Detailed Description
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This is an open label, multi-center, randomized parallel control clinical trial. Patients with persistent atrial fibrillation are 1:1 randomized into the experimental group (driver ablation+ circumferential pulmonary vein isolation) or the control group (stepwise ablation). Postoperative atrial fibrillation recurrence rate and other indicators are analyzed to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation.

Official Title
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Credit-AF: A Randomized Control Study of Driver Ablation Combined With Circumferential Pulmonary Vein Isolation Versus Stepwise Ablation as a Treatment in Patients With Persistent Atrial Fibrillation.

Conditions
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Atrial Fibrillation, Persistent

Intervention / Treatment
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* Procedure: Driver ablation+CPVI
* Procedure: Stepwise ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 80 years old; Persistent AF; nonresponse or intolerance to ≥1 antiarrhythmic drug. - Exclusion Criteria: With uncontrolled congestive heart failure; Having significant valvular disease and/or prosthetic heart valve(s); With myocardial infarction or stroke within 6 months of screening; With Significant congenital heart disease; Ejection fraction was <40% measured by echocardiography; Allergic to contrast media; Contraindication to anticoagulation medications; Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD); Left atrial (LA) thrombus measured by pre-procedure transesophageal echocardiography; Having any contraindication to right or left sided heart catheterization; Previous atrial fibrillation ablation; Presence of an implanted cardioverter-defibrillator; Any cardiac surgery within the past 2 months; Poor general health; Life expectancy less than 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Driver ablation+CPVI<br>Driver ablation plus CPVI (circumferential pulmonary vein isolation) | Procedure: Driver ablation+CPVI<br>* Patients receive driver ablation and CPVI (circumferential pulmonary vein isolation).<br>|
| Active Comparator: Stepwise ablation<br>Stepwise ablation | Procedure: Stepwise ablation<br>* Patients receive stepwise ablation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative atrial fibrillation (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 | 
| Procedural AF termination rate | AF termination is defined as conversion to sinus rhythm or a stable atrial flutter (AFL)/atrial tachycardia (AT). | Before the end of procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative atrial flutter (AFL) or atrial tachycardia (AT) rate | Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration. | up to 24 months after enrollment | 
| Incidence of complications | Complications include: death, atrioesophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, transient ischemic attack (TIA), diaphragmatic paralysis, pneumothorax, heart block, pulmonary vein stenosis, pulmonary edema, pericarditis, and major vascular access complication or bleeding. | up to 2 weeks after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Persistent Atrial Fibrillation, Driver ablation, Stepwise ablation