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

Yonsei University

Status: Unknown

Conditions: Persistent Atrial Fibrillation

Treatments: Drug: Apixaban; Drug: Propafenone

Study type: Interventional

Funder types: Other

Identifiers

NCT02633774

4-2015-0914

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Rhythm control group

Active Comparator group

Description:

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

Treatment:

Drug: Propafenone

Rate control group

Active Comparator group

Description:

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.

Treatment:

Drug: Apixaban