NCT05468528

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 207 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	catheter radiofrequency ablation(individualized stepwise linear without pulmonary vein isolation)	individualized stepwise linear ablation without pulmonary vein isolation
PROCEDURE	catheter radiofrequency ablation(PVI)	pulmonary vein isolation

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-05-01
• Completion: 2024-07-01
• First posted: 2022-07-21
• Last updated: 2022-07-21

Locations

1 site across 1 country: China