NCT05845034

A New Theory of Electrophysiological Mechanism of Atrial Fibrillation

A New Theory of Electrophysiological Mechanism of Atrial Fibrillation and Catheter Ablation Therapy for Atrial Fibrillation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: The Second Affiliated Hospital of Kunming Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The electrophysiological mechanisms of atrial fibrillation remain disagreements. The goal of this clinical trail is to propose a new electrophysiological mechanism hypothesis of atrial fibrillation（AF）,meanwhile, the investigators sought to test the hypothesis that the superposition electrograms (SPEs) recorded during atrial fibrillation could be used as target sites for catheter ablation of atrial fibrillation.

Detailed description

Catheter ablation for atrial fibrillation is a promising therapy, whose success is limited in part by uncertainty in the electrophysiological mechanisms of AF. The investigators recruited 100 subjects including paroxysmal(40%) and persistent (60%) AF. Cases were prospectively treated, in a 2-arm 1:1 design, by ablation SPEs followed by pulmonary vein isolation(PVI) ablation (n=50), or pulmonary vein isolation alone (n =50). All procedures are guided by CARTO (Biosense Webster) electroanatomic mapping system and ablation is performed using open irrigated catheters with contact force (CF) sensing (Thermocool SmartTouch, Biosense Webster). Study Group underwent electroanatomic mapping during AF. Using CARTO to identify areas associated with SPEs. Radiofrequency ablation of the area with SPEs was performed, aiming to eliminate SPEs and convert to sinus rhythm or atrial tachycardia.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	PVI + SPEs ablation	electrophysiology substrate mapping is the critical difference between both groups.
PROCEDURE	PVI ablation	electrophysiology substrate mapping is the critical difference between both groups.

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-10-30
• Completion: 2025-03-30
• First posted: 2023-05-06
• Last updated: 2024-07-09

Locations

1 site across 1 country: China