NCT05153486

Catheter Ablation and Surgical Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis

A Randomized Control Study of Catheter Ablation Versus Surgical Ablation as a Treatment in Patients With 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 evaluating the efficacy and safety of catheter ablation and surgical ablation 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 the group A (circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation), group B (circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion) and group C (surgical ablation). Postoperative recurrence rate and other indicators are analyzed to evaluate the efficacy and safety of catheter ablation and surgical ablation 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 + 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.
PROCEDURE	Surgical ablation	Patients receive surgical ablation.

Timeline

• Start date: 2021-12-01
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2021-12-10
• Last updated: 2021-12-10