EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals With Mild Cognitive Impairment : - The FALCON Study-
概览
- 阶段
- 不适用
- 干预措施
- Atrial fibrillation ablation + antiarrhythmic drugs
- 疾病 / 适应症
- Mild Cognitive Impairment
- 发起方
- Poitiers University Hospital
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Montreal Cognitive Assessmentquestionnaire score evolution 6 months
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
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.
研究者
入排标准
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Atrial fibrillation + antiarrhythmic drugs
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.
干预措施: Atrial fibrillation ablation + antiarrhythmic drugs
Antiarrhythmic drugs alone
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.
干预措施: Antiarrhythmic drug
结局指标
主要结局
Montreal Cognitive Assessmentquestionnaire score evolution 6 months
时间窗: baseline (randomization) and 6 months after randomization
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.
次要结局
- 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)
- Quality of life QOL-AD(baseline (randomization), 6 and 12 months after randomization)