Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04508491
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-04-19
First Post:
2020-08-09
Brief Title:
Cognitive Function in Patients With Persisted Atrial Fibrillation
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
The Best Treatment Strategy for the Reservation of Cognitive Function in Patients With Persisted Atrial Fibrillation
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMART-AF
Brief Summary:
Compare the difference of cognitive function between different treatment strategy in patients with persistent atrial fibrillation
Detailed Description:
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 DTISWI 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
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 DTISWI 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None