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

Mild Cognitive Impairment Clinical Trial

Official title:

EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals With Mild Cognitive Impairment : - The FALCON Study-

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05790707
• Other study ID #: FALCON study
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2023
• Est. completion date: February 2025

Study information

• Verified date: May 2023
• Source: Poitiers University Hospital
• Contact: Rodrigue Garcia
• Phone: 549443729
• Email: rodrigue.garcia[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cognitive Dysfunction
• Mild Cognitive Impairment
• Persistent Atrial Fibrillation

Intervention

Procedure:
• 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.

Drug:
• Antiarrhythmic drug
Amiodarone, flecainide, sotalol, propafenone are the anti arrhythmic drugs allowed.

Locations

Country	Name	City	State
France	University Hospital	Brest
France	University Hospital	Caen
France	University Hospital	Dijon
France	Hopital Européen Georges Pompidou	Paris
France	University Hospital	Poitiers
France	Centre Cardiologique du Nord	Saint-Denis

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	baseline (randomization) and 6 months after randomization
Secondary	Changes in different types of cognitive functions	To assess changes in different cognitive functions measured by a comprehensive neurocognitive assessment between randomization (M0) and 6 months after randomization (M6). The assessed tests are : Free recall/indexed recall 16, WAIS IV "digit memory" subtest, Rapid Frontal Efficiency Battery (BREF) score, Trail Making Test (TMT- GREFEX version), Verbal fluency (GREFEX version) categorical (animals) and literal (letter P), Oral naming of the BETL (Battery for the Evaluation of Language Disorders), STROOP test (GREFEX version), Rey figure, Processing speed index from the WAIS IV.	baseline (randomization) and 6 months after randomization
Secondary	Montreal Cognitive Assessment questionnaire score evolution 12 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 12 months after randomization (M12), compared with "antiarrhythmic drugs alone". The Montreal Cognitive Assessment questionnaire score ranges from 0 to 30. A higher score indicates better cognitive performance.	baseline (randomization) and 12 months after randomization
Secondary	Association between atrial fibrillation burden and cognitive function	To evaluate the association between atrial fibrillation burden and cognitive function as assessed by the change at the Montreal Cognitive Assessment questionnaire score between randomization (M0) and 12 months after randomization (M12). The Montreal Cognitive Assessment questionnaire score ranges from 0 to 30. A higher score indicates better cognitive performance.	baseline (randomization) and 12 months after randomization
Secondary	Quality of life Short Form Survey (SF-12)	To evaluate the effect of "atrial fibrillation ablation + antiarrhythmic drugs" on quality of life assessed by the change at the 12-Item Short Form Survey (SF-12) between randomization (M0), 6 and 12 months after randomization (M6 and M12), compared with "antiarrhythmic drugs alone". Score ranges from 0 to 100, with higher scores indicating better physical and mental health functioning.	baseline (randomization), 6 and 12 months after randomization
Secondary	Quality of life QOL-AD	To evaluate the effect of "atrial fibrillation ablation + antiarrhythmic drugs" on quality of life assessed by the change at the Quality of life in Alzheimer's Disease (QOL-AD) questionnaire scores between randomization (M0), 6 and 12 months after randomization (M6 and M12), compared with "antiarrhythmic drugs alone". Score ranges from 13 to 52. The higher the score, the better quality of life the participant has.	baseline (randomization), 6 and 12 months after randomization