RecruitingNot ApplicableNCT05790707

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

EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals With Mild Cognitive Impairment : - The FALCON Study-

Sponsor

Poitiers University Hospital

Enrollment

120 participants

Start Date

Apr 21, 2023

Study Type

INTERVENTIONAL

Conditions

Mild Cognitive Impairment Persistent Atrial Fibrillation

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.

Eligibility

Min Age: 60 YearsMax Age: 80 Years

Inclusion Criteria8

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 Criteria13

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)

Interventions

PROCEDUREAtrial fibrillation ablation + antiarrhythmic drugs

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.

DRUGAntiarrhythmic drug

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