NCT04229160

Noninvasive 3D Mapping in Persistent Atrial Fibrillation, to Describe Modifications of the Arrhythmogenic Substrate After Pulmonary Vein Isolation and Identify Potential Predicting Factors of Ablation Success

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia in adults. It is a major cause of ischemic stroke and heart failure. Intravascular cardiac ablation of the left atrium by catheter delivery is an efficient treatment to restore sinus rhythm. AF ablation is a class IIa treatment for patients with symptomatic persistent AF refractory or intolerant to antiarrhythmic medication. There are still many debates considering the ablation strategy. The pulmonary veins remain the cornerstone of AF ablation therapy, even in persistent AF. There is a large electrical remodeling occurring in the left atrium between paroxysmal AF, early persistent AF and long-standing persistent AF. However, no multicentric and randomized study has demonstrated so far the interest of targeting other left atrial substrate, such as rotors or focal sources. Our study aims to describe with a noninvasive mapping system the arrhythmogenic substrate of persistent AF \> 6 months pre- and post-cardioversion, and after pulmonary vein isolation.

Conditions

• Atrial Fibrillation, Persistent

Interventions

Type	Name	Description
DEVICE	Noninvasive mapping (Cardioinsight® system)	Noninvasive mapping (Cardioinsight® system) of the left atria before the Atrial fibrilation ablation procedure
DEVICE	long-term cardiac monitoring (LINQ system)	long-term cardiac monitoring (LINQ system) is used to evaluate recurrence rate following AF ablation procedure
PROCEDURE	Atrial Fibrillation ablation procedure	Atrial Fibrillation ablation procedure is done with standard practice

Timeline

• Start date: 2020-06-09
• Primary completion: 2025-06-24
• Completion: 2026-06-24
• First posted: 2020-01-18
• Last updated: 2025-09-17

Locations

4 sites across 1 country: France