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

Poitiers University Hospital

Status: Enrolling

Conditions: Mild Cognitive Impairment; Persistent Atrial Fibrillation

Treatments: Drug: Antiarrhythmic drug; Procedure: Atrial fibrillation ablation + antiarrhythmic drugs

Study type: Interventional

Funder types: Other

Identifiers

NCT05790707

FALCON study

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Atrial fibrillation + antiarrhythmic drugs

Experimental group

Description:

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.

Treatment:

Procedure: Atrial fibrillation ablation + antiarrhythmic drugs

Antiarrhythmic drugs alone

Active Comparator group

Description:

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.

Treatment:

Drug: Antiarrhythmic drug