High-density Mapping-guided bOx Isolation and subsTrate Ablation

Study Overview
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Brief Summary
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This study evaluates the efficacy of high-density mapping guided atrial substrate ablation for persistent atrial fibrillation. 1/5 of the patients with persistent atrial fibrillation undergo pulmonary veins isolation, 2/5 of them pulmonary veins and box isolation while others undergo atrial substrate ablation apart from pulmonary veins and box isolation.

Official Title
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Study of High-density Mapping-guided bOx Isolation and subsTrate Ablation for Persistent Atrial Fibrillation

Conditions
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Atrial Fibrillation, Atrial Remodeling

Intervention / Treatment
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* Procedure: CPVI
* Procedure: CPVI+BOX
* Procedure: CPVI+BOX+SUB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent signed. Age of 18 to 75 years old. Persistent or longstanding persistent atrial fibrillation (≥7 days), which is confirmed by Holter in recent six months. Willing to have catheter ablation for atrial fibrillation. Exclusion Criteria: Accompanied by serious heart diseases including cardiac valvular diseases, congenital heart diseases, hypertrophic obstructive cardiomyopathy, acute myocardium infarction, unstable anginal pectoris and so on. Complete atrioventricular block. An acute stroke or contradiction of anti-coagulation. Hyperthyroidism. Having a history of catheter ablation of atrial fibrillation. Left atrial appendage thrombosis confirmed by transesophageal echocardiography. Pregnancy or lactation. Planning for pregnancy in the near future. Myopathy or active liver disease, including patients with sustained increase of serum transaminase of unknown reason and the ones with increased serum transaminase over three times the upper limit of normal. Patients of severe renal insufficiency with creatinine clearance lower than 30 ml/min.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Circumferential PV isolation<br>Circumferential PV isolation only | Procedure: CPVI<br>* Circumferential PV isolation only<br>|
| Experimental: Circumferential PV and BOX isolation<br>Circumferential PV and BOX isolation | Procedure: CPVI+BOX<br>* Circumferential PV and BOX isolation<br>|
| Experimental: circumferential PV and BOX isolation with substrate ablation<br>Atrial substrate ablation apart from circumferential PV and BOX isolation | Procedure: CPVI+BOX+SUB<br>* Atrial substrate ablation apart from circumferential PV and BOX isolation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sinus rhythm maintenance rate | Holter is performed 12months after the procedure and heart rhythm is recorded. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular ejection fraction | LVEF is evaluated by echocardiography 12months after the procedure. | 12 months | 
| Stroke or embolic events | History of stroke or embolic events is taken at each follow-up during the period of 12 months after procedure, and if necessary, radiographic examinations will be performed. | 12 months | 
| Atrial fibrosis | Atrial substrate mapping is performed before and after catheter ablation in one day to evaluate the atrial fibrosis. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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catheter ablation