Catheter Ablation of Longstanding Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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This randomized prospective study compared three ablation strategies in patients with longstanding persistent atrial fibrillation (LPeAF). It also explored the best procedural endpoint from among the following: circumferential pulmonary vein isolation (PVI)+left atrial (LA) linear lesions (roof line, mitral isthmus)+complex fractionated atrial electrogram (CFAE) ablation, PVI+LA linear lesions +cavotricuspid isthmus (CTI) ablation +CFAE ablation, and PVI+CFAE ablation.

Detailed Description
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Patients were randomized into three ablation groups: group A (n=100): PVI+LA linear ablation (roof line and mitral isthmus) +CFAE ablation; group B (n=100): PVI+linear ablation (roof line, mitral isthmus, and CTI) +CFAE ablation; group C (n=100), PVI+CFAE ablation.

Official Title
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Optimal Ablation Endpoint for Longstanding Persistent Atrial Fibrillation: a Randomized Prospective Study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: PVI
* Procedure: LA linear ablation
* Procedure: CFAE ablation
* Procedure: linear ablation
* Device: CARTO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with longstanding persistent atrial fibrillation (lasting for>1 year) Exhibited refractoriness to at least one antiarrhythmic drug Left atrial diameter <=60mm Exclusion Criteria: Patients 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 warfarin or heparin 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 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PVI+LA linear ablation +CFAE ablation<br>The ablation procedure for atrial fibrillation guided by CARTO system, including PVI, LA linear ablation (roof line and mitral isthmus)and CFAE ablation. | Procedure: PVI<br>* PVI was the complete isolation of all PVs, which was confirmed by entrance and/or exit block into or from the PV antra.<br>Procedure: LA linear ablation<br>* LA linear ablation include mitral isthmus ablation and roof line ablation. Mitral isthmus ablation (from the mitral annulus to the left inferior PV) was performed first, followed by roof line ablation (between the right and left superior PVs).<br>Procedure: CFAE ablation<br>* Ablation catheter was maintained in a stable position when the electrograms were being recorded for at least 5 s to avoid artifacts.The procedural endpoint of CFAEs was the complete elimination of fragmented atrial activity in local electrograms.<br>Device: CARTO<br>* 3 dimensional mapping system<br>|
| Active Comparator: PVI+linear ablation +CFAE ablation<br>The ablation procedure for atrial fibrillation guided by CARTO system, including PVI,roof line and mitral isthmus,cavotricuspid isthmus abaltion and CFAE ablation. | Procedure: PVI<br>* PVI was the complete isolation of all PVs, which was confirmed by entrance and/or exit block into or from the PV antra.<br>Procedure: LA linear ablation<br>* LA linear ablation include mitral isthmus ablation and roof line ablation. Mitral isthmus ablation (from the mitral annulus to the left inferior PV) was performed first, followed by roof line ablation (between the right and left superior PVs).<br>Procedure: CFAE ablation<br>* Ablation catheter was maintained in a stable position when the electrograms were being recorded for at least 5 s to avoid artifacts.The procedural endpoint of CFAEs was the complete elimination of fragmented atrial activity in local electrograms.<br>Procedure: linear ablation<br>* Right atrial CTI ablation was performed during SR.<br>Device: CARTO<br>* 3 dimensional mapping system<br>|
| Active Comparator: PVI+CFAE ablation<br>The ablation procedure for atrial fibrillation guided by CARTO system, including PVI and CFAE ablation. | Procedure: PVI<br>* PVI was the complete isolation of all PVs, which was confirmed by entrance and/or exit block into or from the PV antra.<br>Procedure: CFAE ablation<br>* Ablation catheter was maintained in a stable position when the electrograms were being recorded for at least 5 s to avoid artifacts.The procedural endpoint of CFAEs was the complete elimination of fragmented atrial activity in local electrograms.<br>Device: CARTO<br>* 3 dimensional mapping system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first documented recurrence of atrial arrhythmias | Time to first documented recurrence of atrial arrhythmias after the first ablation procedure and after the final ablation procedure | 2-year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure duration at ablation | Minutes elapsed from the first puncture of the femoral vein to the removal of the last catheter | At the end of the first ablation procedure | 
| Ablation time at ablation | Minutes elapsed from the onset of the first energy delivery to the end of the last energy delivery | At the end of the first ablation procedure ] | 
| Fluoroscopy time at ablation | Minutes of fluoroscopy used during the entire ablation procedure | At the end of the first ablation procedure | 
| Complications | Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death. | 2-year follow-up | 
| Type of recurrent arrhythmia | Specific type of recurrent atrial arrhythmia | 2-year follow-up | 
| Number of redo procedures | Number of redo procedures，including two or more procedures | 2-year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ablation Linear Lesions