Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation, Persistent
Keywords: pulmonary vein isolation
cardioversion
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of focal sources and rotors in atrial segments
timeFrame: within 1 hour post-cardioversion procedure
measure: Number of focal sources and rotors in atrial segments
timeFrame: within 1 hour post-Pulmonary Vein Isolation procedure
Secondary outcomes:
measure: Number of Atrial Fibrillation recurrence following AF ablation procedure
timeFrame: 1 year post-procedure
measure: Number of success of Atrial Fibrillation induction after initial electrical cardioversion
timeFrame: within 2 hours
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
city: Dieppe
country: France
facility: Dieppe Hospital
city: Le Havre
country: France
facility: Groupe Hospitalier du Havre
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Frédéric ANSELME, Pr
role: PRINCIPAL_INVESTIGATOR
References: