Comparison of Brain Perfusion in Rhythm Control and Rate Control of Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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Atrial fibrillation (AF) is associated with impaired cognitive function (CogF) and/or dementia, but it is unclear whether rhythm control of AF improves CogF or brain perfusion. The hypothesis is rhythm control of AF improves CogF by increasing brain perfusion with hemodynamic amelioration compared to AF state. We will randomize the patients with persistent AF to rhythm control group and rate control group, and check baseline and 3rd month cognitive function (K-MOCA score) and brain perfusion CT. K-MOCA score and brain perfusion CT findings will be compared between rhythm control group and rate control group of persistent AF.

Official Title
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Comparison of Brain Perfusion in Rhythm Control and Rate Control of Persistent Atrial Fibrillation: Prospective Randomized Trial

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Drug: Propafenone
* Drug: Apixaban


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with persistent Atrial fibrillation (20 80 years old) LA diameter < 55mm patients possible to anticoagulation and anti arrhythmic drug Exclusion Criteria: Structural cardiac disease Contraindication to brain perfusion CT Catheter ablation history for AF, Cardiac surgery active internal bleeding Impossible to anticoagulation or antiarrhythmic drug valvular AF ((MA> GII, Mechanical valve, Mitral valve replacement) LVEF < 30% With severe medical disease Expected survival < 1 year Severe alcoholics, drug addiction

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rhythm control group<br>1. Start AAD right after evaluating for LA size, EF, LA thrombus, and presence of CAD during anticoagulation 2. check the echo, brain perfusion CT and K-MOCA on baseline 3. confirm a thrombus through the TEE 4. Cardioversion after 1 month 5. Rhythm FU schedule (2012 ACC/AHA/ESC guidelines) 6. If AF recur, RFCA 7. check the brain perfusion CT, K-MOCA after 3M and 12M | Drug: Propafenone<br>* AAD(antiarrhythmic drug)<br>|
| Active Comparator: Rate control group<br>1. No AAD, just anticoagulation 2. HR control between 60 110bpm (with beta blocker, calcium channel blocker, digoxin) 3. check the echo, brain perfusion CT and K-MOCA on baseline 4. check the brain perfusion CT and K-MOCA after 3M and 12M 5. Without the treatment about antiarrythmia and rhythm control, diffication of rate control, the subject will be drop out for study. | Drug: Apixaban<br>* anti-coagulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| K-MOCA(Korean version of Montreal Cognitive Assessment) |  | 12 months after the enrollment | 
| Brain perfusion CT |  | 12 months after the enrollment |