National Taiwan University Hospital
Taipei, Taiwan
NCT Number: NCT04508491
Compare the difference of cognitive function between different treatment strategy in patients with persistent atrial fibrillation
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Taipei, Taiwan
The prevalence of atrial fibrillation (AF) had been increasing for the past decade. The increase of AF was attributed to the aging of the population and the increased awareness of the disease among people and the primary physicians. However, we have not achieved the consensus whether aggressive rhythm control or conservative rate control is better in a patient with asymptomatic persisted AF. We do prescribe anti-coagulant for stroke prevention, but which treatment strategy is best for the patients is uncertain.
The clinical trial of catheter-based ablation for rhythm control compared to traditional medication control has not shown the benefit of reducing all-cause mortality, but it did show a reduction of re-hospitalization and the recurrence of AF. On the contrary, the study in heart failure patients had shown a significant benefit applying catheter-based rhythm control strategy to reduce all-cause mortality. The different results of these two trials told us the benefit of rhythm control is not easily to be seen in a short-term, but could be seen in a long term or in high risk patients. The association between AF and cognitive impairment has also been reported in observation cohort. However, there is no sold evidence in clinical trials to show the improvement of cognitive function by treating atrial fibrillation. One study did show improvement of cognitive function with questionnaire, but the other showed new lesion detected by traditional magnetic resonance imaging (MRI) after ablation, though the lesion resolved after one year of follow-up. There is no clear answer to which treatment strategy is better for the patients' cognitive function。 Therefore, we designe a prospective, randomized, blind endpointtrial. We will enroll the patients with persisted AF, and use advanced MRI (DTI/SWI) and questionnaire to longitudinally study the cognitive function change of the patients before and after the initiation of anti-coagulant agents, before and after the catheter-based ablation, and use this as a surrogate to understand the best treatment strategy for these AF patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Rhythm control with medications or any procedure
Rate control
Time frame: 12 months
MOCA questionnaire
Time frame: 12 months
brain MRI
Time frame: 12 months
SF-36 questionnaire
Time frame: 12 months
Time frame: 12 months
National Taiwan University Hospital
Other
The Best Treatment Strategy for the Reservation of Cognitive Function in Patients With Persisted Atrial Fibrillation
Acronym: SMART-AF
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