Clinical trial NCT05790707: EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals with Mild Cognitive Impairment
Official title: EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals with Mild Cognitive Impairment : - the FALCON Study-
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Persistent Atrial Fibrillation
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Patients aged 60 to 85 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)

Primary outcomes:
measure: Montreal Cognitive Assessmentquestionnaire score evolution 6 months
timeFrame: baseline (randomization) and 6 months after randomization
Secondary outcomes:
measure: Baseline characteristics associated with Montreal Cognitive Assessment score improvement
timeFrame: baseline (randomization) and 6 months after randomization
measure: Changes in different types of cognitive functions
timeFrame: baseline (randomization) and 6 months after randomization
measure: Montreal Cognitive Assessment questionnaire score evolution 12 months
timeFrame: baseline (randomization) and 12 months after randomization
measure: Association between atrial fibrillation burden and cognitive function
timeFrame: baseline (randomization) and 12 months after randomization
measure: Quality of life Short Form Survey (SF-12)
timeFrame: baseline (randomization), 6 and 12 months after randomization
measure: Quality of life QOL-AD
timeFrame: baseline (randomization), 6 and 12 months after randomization
Other outcomes:
Locations:
city: Brest
country: France
facility: University Hospital
city: Caen
country: France
facility: University Hospital
city: Dijon
country: France
facility: University Hospital
city: Paris
country: France
facility: Hopital Européen Georges Pompidou
city: Poitiers
country: France
facility: University Hospital
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord
Study officials:
References: