EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals With Mild Cognitive Impairment
Mild Cognitive Impairment, Persistent Atrial Fibrillation
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment
Eligibility Criteria
Inclusion Criteria: Patients aged 60 to 85 years Persistent atrial fibrillation Patients with an indication for cardiac rhythm control. Montreal Cognitive Assessment score between 18 and 25 points corresponding to mild cognitive impairment Free subject, not under temporary or permanent guardianship and not subject to subordination Subject understanding and accepting the constraints of the study Patient covered by French national health insurance or benefiting from it through a third party Subject has given written consent to the study after having received clear and complete information Exclusion Criteria: Impossibility to perform the neuropsychological evaluation (communication problems such as hearing loss or aphasia, language barrier) History of clinical stroke Presence of a bruit at carotid auscultation or history of severe carotid stenosis History or suspicion of neurodegenerative disease (Parkinson's disease, Alzheimer's disease, Huntington's disease and amyotrophic lateral sclerosis...), bipolar disorder, schizophrenia, severe depression or amyloidosis Patient with history of previous atrial fibrillation ablation Patient undergoing flutter ablation or atrial tachycardia ablation (not atrial fibrillation ablation) Contraindication to atrial fibrillation ablation (intracardiac thrombus, severe pulmonary hypertension, mechanical mitral valve prosthesis or contraindication to anticoagulation,…) Contraindication to antiarrhythmic drugs, or to implantable cardiac monitor Patient with very advanced persistent atrial fibrillation, i.e., for more than 3 years or with a left atrial diameter >60 mm in parasternal long axis section or a left atrial volume > 48ml/m2 in echocardiography Subject with a life expectancy of less than 24 months at study enrolment Inability to consent Persons benefiting from a reinforced protection, namely minors, persons deprived of liberty by a judicial or administrative decision, adults under legal protection, and finally patients in emergency situations Pregnant or breastfeeding women, women at age to procreate and not using effective contraception (hormonal/barrier: oral, parenteral, percutaneous implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy)
Sites / Locations
- University Hospital
- University Hospital
- University Hospital
- Hopital Européen Georges Pompidou
- University HospitalRecruiting
- Centre Cardiologique du Nord
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Atrial fibrillation + antiarrhythmic drugs
Antiarrhythmic drugs alone
The ablation can be done with different sources of energy (radiofrequency, cryoballoon or pulsed field ablation). Different sets of lesions can be performed but the cornerstone is pulmonary vein isolation which will be mandatory. Antiarrhythmic drugs management will be at the operator discretion. Some operators may stop antiarrhythmic drugs after atrial fibrillation ablation.
Antiarrhythmic drugs available available are amiodarone, flecainide, propafenone, sotalol. If not previously started, patients randomized to antiarrhythmic drugs arm should start antiarrhythmic drugs therapy within 1 week of randomization. Apart from these recommendations, antiarrhythmic drugs management will be at the operator discretion.