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

NCT04229160 | Active Not Recruiting

• 1 other identifier: 2018/0418/HP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

pulmonary vein isolation; cardioversion

Outcome Measures

Primary Outcomes (2)

• Number of focal sources and rotors in atrial segments

  within 1 hour post-cardioversion procedure

• Number of focal sources and rotors in atrial segments

  within 1 hour post-Pulmonary Vein Isolation procedure

Secondary Outcomes (2)

• Number of Atrial Fibrillation recurrence following AF ablation procedure

  1 year post-procedure

• Number of success of Atrial Fibrillation induction after initial electrical cardioversion

  within 2 hours

Study Arms (1)

patient with persistent atrial fibrillation

EXPERIMENTAL

persistent atrial fibrillation is defined as lasting longer than 6 months documented by a 24h holter monitoring

Device: Noninvasive mapping (Cardioinsight® system); Device: long-term cardiac monitoring (LINQ system); Procedure: Atrial Fibrillation ablation procedure

Interventions

Noninvasive mapping (Cardioinsight® system) DEVICE

Noninvasive mapping (Cardioinsight® system) of the left atria before the Atrial fibrilation ablation procedure

patient with persistent atrial fibrillation

long-term cardiac monitoring (LINQ system) DEVICE

long-term cardiac monitoring (LINQ system) is used to evaluate recurrence rate following AF ablation procedure

patient with persistent atrial fibrillation

Atrial Fibrillation ablation procedure PROCEDURE

Atrial Fibrillation ablation procedure is done with standard practice

patient with persistent atrial fibrillation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with documented persistent Atrial Fibrillation lasting longer than 6 months documented by 24h holter monitoring
• Age between 18 and 75 years
• Efficient oral anticoagulation during at least 1 month before the procedure
• Social security affiliation
• Feasible patient follow-up
• Patient willing to comply with study requirements and give informed consent to participate in this clinical study
• Indication for Pulmonary Vein isolation

You may not qualify if:

• Previous atrial fibrillation ablation
• Previous left atrial ablation or surgery
• Atrial fibrillation without spontaneous RR interval \> 1000ms and with LVEF \< 35% (measured by TTE)
• Presence of a mechanical mitral valve
• Current intracardiac thrombus
• Any condition contraindicating chronic anticoagulation
• Uncontrolled hyperthyroidism
• Anteroposterior LA diameter \> 55 mm measured by TTE
• Body mass index ≥ 40 kg/m2

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (4)

Caen University Hospital

Caen, France

Location

Dieppe Hospital

Dieppe, France

Location

Groupe Hospitalier du Havre

Le Havre, France

Location

Rouen University Hospital

Rouen, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frédéric ANSELME, Pr

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 18, 2020
• Study Start: June 9, 2020
• Primary Completion: June 24, 2025
• Study Completion (Estimated): June 24, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)