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"Atrial fibrillation (AF) is an arrhythmic disease that increases especially in the elderly, increasing the risk of ischemic stroke by 5 times and is a major cause of dementia and cognitive impairment.
Cognitive dysfunction accompanying AF occurs regardless of the presence or absence of stroke, and AF itself is known to affect cognitive function.
However, since cognitive dysfunction is also affected by various accompanying chronic diseases, whether the cognitive dysfunction accompanying AF is due to subclinical ischemic stroke, cerebral hypoperfusion due to reduced cardiac output, inflammatory reaction or platelet dysfunction are unclear.
Recently, this research team reported an improvement in cognitive function with active sinus rhythm therapy such as AF catheter ablation. Nevertheless, it has not yet been proven whether such active and invasive AF treatment affects the improvement of cognitive function or depression by a randomized clinical trial.
In this prospective randomized clinical comparative study, the investigators will compare the AF catheter ablation group and drug therapy group in terms of cognitive function tests and depression psychological tests at baseline and a year after treatment. Our hypothesis is that AF catheter ablation is superior to drug therapy to improve cognitive function and depressive mood.
Study design
Progress and rhythm/ ECG follow-up
Follow-up observation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial fibrillation catheter ablation group | Experimental | catheter ablation |
|
| Medical therapy group | Active Comparator | standard treatment include anti-arrhythmic drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atrial fibrillation catheter ablation group | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cognitive function, depression, and anxiety scale after catheter ablation or drug treatment after 1 year of randomization | Compasison of scale change using the Moca questionnaire. | 1 year |
| Changes in depression scale after catheter ablation or drug treatment after 1 year of randomization | Compasison of scale change using the CES-D questionnaire. | 1 year |
| Changes in anxiety scale after catheter ablation or drug treatment after 1 year of randomization | Compasison of scale change using the GAD-7 questionnaire. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Differences according to AF type | 1year | |
| Differences in adverse effects of ablation vs. medications | 1year | |
| Differences in MACE, Death, and Readmission rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui-Nam Pak | Contact | 82-2-2228-8459 | hnpak@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Hui-Nam Pak | Yonsei University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| Medical therapy group | Drug |
|
|
| 1year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |