Clinical Value of Linear Ablation Without Pulmonary Vein Isolation in Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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Based on previous theoretical foundation and clinical practice experience, the investigators further propose a multi-center randomized prospective trial to compare the pure linear ablation strategy without pulmonary vein isolation to traditional PVI ablation for persistent AF. population size is 207. The participants will be randomized to the linear ablation group and PVI ablation group with a 2:1 ratio. the follow-up period is 12 months. The primary outcome is freedom from atrial fibrillation, the secondary outcome is complications related to ablation.

Detailed Description
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Pulmonary vein isolation is recommended as the cornerstone of catheter ablation of atrial fibrillation by current guidelines, However, meta-analysis suggests that the success rate of continuous pulmonary vein isolation for persistent atrial fibrillation is only 43%. Therefore, in addition to pulmonary vein isolation, further research on substrate modification in the treatment of atrial fibrillation is particularly important. Based on our previous theoretical foundation and clinical practice experience, the investigators further propose a multi-center randomized prospective trial to compare the pure linear ablation strategy without pulmonary vein isolation to traditional PVI ablation for persistent AF. The linear ablation is performed on the basis of Ω-type linear ablation. Further stepwise ablation of the left atrial anterior wall increases the blockage of the LA roof and the MVA isthmus. Ablation in CS or ethanol ablation of vein of Marshall. Also, epicardial ablation on the roof or rigid between LAA-LPVs may be applied if necessary.

Official Title
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Clinical Value of Linear Ablation Without Pulmonary Vein Isolation in Persistent Atrial

Conditions
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Atrial Fibrillation, Persistent, Atrial Fibrillation

Intervention / Treatment
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* Procedure: catheter radiofrequency ablation(individualized stepwise linear without pulmonary vein isolation)
* Procedure: catheter radiofrequency ablation(PVI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients suffering from persistent atrial fibrillation and referred to catheter ablation therapy. patients agreeing to be enrolled， with the informed consent signed Exclusion Criteria: Sinus rhythm at the time of recruitment; Age less than 18 years old or older than 75 years; Transthoracic echocardiography suggests that the anteroposterior diameter of the left atrium is greater than 55 mm; History of previous radiofrequency ablation of atrial fibrillation or surgical ablation History; Left atrial thrombus recorded by ultrasound or CT; Combined with severe lung disease; Previous history of cardiac surgery; Patients with hyperthyroidism, atrial septal defect, mitral stenosis, or severe coronary heart disease requiring further treatment

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 |
| --- | --- |
| Experimental: linear ablation group<br>The linear ablation is performed on the basis of Ω-type linear ablation. Further stepwise ablation of the left atrial anterior wall increases the blockage of the LA roof and the MVA isthmus. Ablation in CS or ethanol ablation of vein of Marshall. Also, epicardial ablation on the roof or rigid between LAA-LPVs may be applied if necessary. | Procedure: catheter radiofrequency ablation(individualized stepwise linear without pulmonary vein isolation)<br>* individualized stepwise linear ablation without pulmonary vein isolation<br>|
| Other: PVI group<br>pulmonary vein isolation ablation alone | Procedure: catheter radiofrequency ablation(PVI)<br>* pulmonary vein isolation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from atrial fibrillation at 1 year | Recurrent AF is defined as documented AF (through 12-lead ECG) episode lasting >30 seconds after a 3-month blanking period. | 12 months after the ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications related to ablation | Tamponade, pericarditis and perforation following the ablation procedure | 12 months after the ablation | 

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