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

NCT ID: NCT02633774

Last Updated: 2019-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2020-11-30

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.

Detailed Description

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Conditions

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Persistent Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rhythm control group

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

Group Type ACTIVE_COMPARATOR

Propafenone

Intervention Type DRUG

AAD(antiarrhythmic drug)

Rate control group

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.

Group Type ACTIVE_COMPARATOR

Apixaban

Intervention Type DRUG

anti-coagulation

Interventions

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Propafenone

AAD(antiarrhythmic drug)

Intervention Type DRUG

Apixaban

anti-coagulation

Intervention Type DRUG

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hui-Nam Park, MD, Ph.D

Role: CONTACT

82-2-2228-8459

Facility Contacts

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Hui-Nam Pak, M.D., Ph.D.

Role: primary

82-2-2228-8459

Other Identifiers

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4-2015-0914

Identifier Type: -

Identifier Source: org_study_id

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