Clinical Value of Linear Ablation Without Pulmonary Vein Isolation in Persistent Atrial Fibrillation (CLEAR AF II)

National Center for Cardiovascular Diseases

Status: Not yet enrolling

Conditions: Atrial Fibrillation, Persistent; Atrial Fibrillation

Treatments: Procedure: catheter radiofrequency ablation(individualized stepwise linear without pulmonary vein isolation); Procedure: catheter radiofrequency ablation(PVI)

Study type: Interventional

Funder types: Other

Identifiers

NCT05468528

2021-1627

Details and patient eligibility

About

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.

Full 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.

Enrollment: 207 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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207 participants in 2 patient groups

linear ablation group

Experimental group

Description:

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.

Treatment:

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

PVI group

Other group

Description:

pulmonary vein isolation ablation alone

Treatment:

Procedure: catheter radiofrequency ablation(PVI)