EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals With Mild Cognitive Impairment

Summary

The goal of this clinical trial is to evaluate the effect of catheter ablation of persistent atrial fibrillation on cognitive function in patients with mild cognitive impairment. Participants will be randomized into antiarrhythmic drugs alone or atrial fibrillation ablation + antiarrhythmic drugs.

Interventions

• Atrial fibrillation ablation + antiarrhythmic drugs · PROCEDURE

  Atrial fibrillation ablation will be performed with endovascular catheters and will be done either with radiofrequency, cryoballoon or pulsed field ablation. Amiodarone, flecainide, sotalol, propafenone are the anti arrhythmic drugs allowed.

• Antiarrhythmic drug · DRUG

  Amiodarone, flecainide, sotalol, propafenone are the anti arrhythmic drugs allowed.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* Patients aged 60 to 80 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 (8)

• CHU Angers, Angers, France · Recruiting
• University Hospital, Brest, France · Recruiting
• University Hospital, Caen, France · Recruiting
• University Hospital, Dijon, France · Recruiting
• CHU Grenoble, Grenoble, France · Recruiting
• La Timone, Marseille, France · Recruiting
• University Hospital, Poitiers, France · Recruiting
• Centre Cardiologique du Nord, Saint-Denis, France · Not yet recruiting