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

Primary Purpose

Mild Cognitive Impairment, Persistent Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Atrial fibrillation ablation + antiarrhythmic drugs
Antiarrhythmic drug
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Hospital
  • University Hospital
  • University Hospital
  • Hopital Européen Georges Pompidou
  • University HospitalRecruiting
  • Centre Cardiologique du Nord

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Atrial fibrillation + antiarrhythmic drugs

Antiarrhythmic drugs alone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 5, 2023
Last Updated
May 25, 2023
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05790707
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2023 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Persistent Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atrial fibrillation + antiarrhythmic drugs
Arm Type
Experimental
Arm Description
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.
Arm Title
Antiarrhythmic drugs alone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Atrial fibrillation ablation + antiarrhythmic drugs
Intervention Description
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
Drug
Intervention Name(s)
Antiarrhythmic drug
Intervention Description
Amiodarone, flecainide, sotalol, propafenone are the anti arrhythmic drugs allowed.
Primary Outcome Measure Information:
Title
Montreal Cognitive Assessmentquestionnaire score evolution 6 months
Description
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.
Time Frame
baseline (randomization) and 6 months after randomization
Secondary Outcome Measure Information:
Title
Baseline characteristics associated with Montreal Cognitive Assessment score improvement
Description
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.
Time Frame
baseline (randomization) and 6 months after randomization
Title
Changes in different types of cognitive functions
Description
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.
Time Frame
baseline (randomization) and 6 months after randomization
Title
Montreal Cognitive Assessment questionnaire score evolution 12 months
Description
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.
Time Frame
baseline (randomization) and 12 months after randomization
Title
Association between atrial fibrillation burden and cognitive function
Description
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.
Time Frame
baseline (randomization) and 12 months after randomization
Title
Quality of life Short Form Survey (SF-12)
Description
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.
Time Frame
baseline (randomization), 6 and 12 months after randomization
Title
Quality of life QOL-AD
Description
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.
Time Frame
baseline (randomization), 6 and 12 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigue Garcia
Phone
549443729
Ext
+33
Email
rodrigue.garcia@chu-poitiers.fr
Facility Information:
Facility Name
University Hospital
City
Brest
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Mansourati
Facility Name
University Hospital
City
Caen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Ollitrault
Facility Name
University Hospital
City
Dijon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Guenancia
Facility Name
Hopital Européen Georges Pompidou
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eloi Marijon
Facility Name
University Hospital
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigue Garcia
Facility Name
Centre Cardiologique du Nord
City
Saint-Denis
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Piot

12. IPD Sharing Statement

Learn more about this trial

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

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