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

Not Applicable

• Conditions: Persistent Atrial Fibrillation
• Interventions: Drug: Propafenone; Drug: Apixaban

• Registration Number: NCT02633774
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-12-07
• Study First Submitted QC: 2015-12-14
• Study First Posted: 2015-12-17
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-25
• Last Update Posted: 2019-01-28
• Primary Completion: 2020-11
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rhythm control group	Propafenone	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
Rate control group	Apixaban	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.

Primary Outcome Measures

Name	Time	Method
K-MOCA(Korean version of Montreal Cognitive Assessment)	12 months after the enrollment
Brain perfusion CT	12 months after the enrollment

Trial Locations

Locations (1)

Severance Cardiovascular Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of