NCT05085912

Driver Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis.

A Randomized Control Study of Driver Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis: a Chinese Registry Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation with severe atrial fibrosis.

Detailed description

This is an open label, randomized parallel control clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are 1:1:1 randomized into group A (circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation), group B (circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation) and group C (circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion). Postoperative recurrence rate and other indicators are analyzed to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation with severe atrial fibrosis.

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation	Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with bi-atrial mapping and driver ablation.
PROCEDURE	Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation	Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with posterior wall box isolation.
PROCEDURE	Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion	Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with vein of Marshall ethanol infusion.

Timeline

• Start date: 2021-11-01
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2021-10-20
• Last updated: 2021-10-20