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

NCT ID: NCT05468528

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-07-01

Brief Summary

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

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.

Conditions

Atrial Fibrillation, Persistent; Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

linear ablation group

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.

Group Type: EXPERIMENTAL

catheter radiofrequency ablation(individualized stepwise linear without pulmonary vein isolation)

Intervention Type: PROCEDURE

individualized stepwise linear ablation without pulmonary vein isolation

PVI group

pulmonary vein isolation ablation alone

Group Type: OTHER

catheter radiofrequency ablation(PVI)

Intervention Type: PROCEDURE

pulmonary vein isolation

Interventions

catheter radiofrequency ablation(individualized stepwise linear without pulmonary vein isolation)

individualized stepwise linear ablation without pulmonary vein isolation

Intervention Type: PROCEDURE

catheter radiofrequency ablation(PVI)

pulmonary vein isolation

Intervention Type: PROCEDURE

Eligibility Criteria

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

1. Sinus rhythm at the time of recruitment;

2. Age less than 18 years old or older than 75 years;

3. Transthoracic echocardiography suggests that the anteroposterior diameter of the left atrium is greater than 55 mm;

4. History of previous radiofrequency ablation of atrial fibrillation or surgical ablation History;

5. Left atrial thrombus recorded by ultrasound or CT;

6. Combined with severe lung disease;

7. Previous history of cardiac surgery;

8. Patients with hyperthyroidism, atrial septal defect, mitral stenosis, or severe coronary heart disease requiring further treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

ZHONGNANSHAN MEDICAL FOUNDATION OF GUANGDONG PROVINCE

UNKNOWN

Sponsor Role: collaborator

Beijing Hospital

OTHER_GOV

Sponsor Role: collaborator

Wuhan Asia Heart Hospital

OTHER

Sponsor Role: collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role: collaborator

Fuwai Yunnan Cardiovascular Hospital

OTHER

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: collaborator

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, , China

Countries

China

Other Identifiers

2021-1627

Identifier Type: -

Identifier Source: org_study_id