EfFect of Ablation of Persistent AtriaL Fibrillation on C... | NCT05790707

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Atrial fibrillation + antiarrhythmic drugs	Experimental	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.	Procedure: Atrial fibrillation ablation + antiarrhythmic drugs
Antiarrhythmic drugs alone	Active Comparator	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.	Drug: Antiarrhythmic drug

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Montreal Cognitive Assessmentquestionnaire score evolution 6 months	To evaluate the effect of "atrial fibrillation ablation + antiarrhythmic drugs" on cognitive function as assessed by the change at the Montreal Cognitive Assessment questionnaire score between randomization (M0) and 6 months after randomization (M6), compared with "antiarrhythmic drugs alone" in patients with persistent atrial fibrillation associated with mild cognitive impairment. The Montreal Cognitive Assessment questionnaire score ranges from 0 to 30. A higher score indicates better cognitive performance.	baseline (randomization) and 6 months after randomization

Secondary Outcomes

Measure	Description	Time Frame
Baseline characteristics associated with Montreal Cognitive Assessment score improvement	To define the baseline characteristics associated with Montreal Cognitive Assessment improvement between randomization (M0) and 6 months after randomization (M6) in patients with mild cognitive impairment and persistent atrial fibrillation undergoing atrial fibrillation ablation. The Montreal Cognitive Assessment questionnaire score ranges from 0 to 30. A higher score indicates better cognitive performance.

Eligibility Module

Eligibility Criteria

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)

ID	Term
D060825	Cognitive Dysfunction
D001281	Atrial Fibrillation

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D002317	Cardiovascular Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses