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
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University Hospital, Rouen
- Enrollment
- 50
- Locations
- 4
- Primary Endpoint
- Number of focal sources and rotors in atrial segments
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Number of focal sources and rotors in atrial segments
Time Frame: within 1 hour post-Pulmonary Vein Isolation procedure
Secondary Outcomes
- Number of success of Atrial Fibrillation induction after initial electrical cardioversion(within 2 hours)
- Number of Atrial Fibrillation recurrence following AF ablation procedure(1 year post-procedure)