EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals With Mild Cognitive Impairment
1 other identifier
interventional
120
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2023
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2023
CompletedFirst Posted
Study publicly available on registry
March 30, 2023
CompletedStudy Start
First participant enrolled
April 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
January 23, 2026
January 1, 2026
3.7 years
February 5, 2023
January 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 (6)
Baseline characteristics associated with Montreal Cognitive Assessment score improvement
baseline (randomization) and 6 months after randomization
Changes in different types of cognitive functions
baseline (randomization) and 6 months after randomization
Montreal Cognitive Assessment questionnaire score evolution 12 months
baseline (randomization) and 12 months after randomization
Association between atrial fibrillation burden and cognitive function
baseline (randomization) and 12 months after randomization
Quality of life Short Form Survey (SF-12)
baseline (randomization), 6 and 12 months after randomization
- +1 more secondary outcomes
Study Arms (2)
Atrial fibrillation + antiarrhythmic drugs
EXPERIMENTALThe 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.
Antiarrhythmic drugs alone
ACTIVE COMPARATORAntiarrhythmic 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.
Interventions
Amiodarone, flecainide, sotalol, propafenone are the anti arrhythmic drugs allowed.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
CHU Angers
Angers, France
University Hospital
Brest, France
University Hospital
Caen, France
University Hospital
Dijon, France
CHU Grenoble
Grenoble, France
La Timone
Marseille, France
University Hospital
Poitiers, France
Centre Cardiologique du Nord
Saint-Denis, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2023
First Posted
March 30, 2023
Study Start
April 21, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
January 23, 2026
Record last verified: 2026-01