Atrial Fibrillation, Persistent
Conditions
Keywords
pulmonary vein isolation, cardioversion
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.
Interventions
DEVICENoninvasive mapping (Cardioinsight® system)
Noninvasive mapping (Cardioinsight® system) of the left atria before the Atrial fibrilation ablation procedure
DEVICElong-term cardiac monitoring (LINQ system)
long-term cardiac monitoring (LINQ system) is used to evaluate recurrence rate following AF ablation procedure
PROCEDUREAtrial Fibrillation ablation procedure
Atrial Fibrillation ablation procedure is done with standard practice
Sponsors
University Hospital, Rouen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of focal sources and rotors in atrial segments | within 1 hour post-cardioversion procedure |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed