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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-21

Study Completion Date

2027-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Mild Cognitive Impairment Persistent Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Atrial fibrillation + antiarrhythmic drugs

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.

Group Type EXPERIMENTAL

Atrial fibrillation ablation + antiarrhythmic drugs

Intervention Type 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 drugs alone

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.

Group Type ACTIVE_COMPARATOR

Antiarrhythmic drug

Intervention Type DRUG

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

Interventions

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Atrial 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.

Intervention Type PROCEDURE

Antiarrhythmic drug

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No