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

Primary Purpose

Persistent Atrial Fibrillation

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Propafenone

Apixaban

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Severance Cardiovascular Hospital, Yonsei University Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Rhythm control group

Rate control group

Arm 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

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.

Outcomes

Primary Outcome Measures

K-MOCA(Korean version of Montreal Cognitive Assessment)

Brain perfusion CT

Secondary Outcome Measures

Full Information

NCT ID

NCT02633774

First Posted

December 7, 2015

Last Updated

January 25, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02633774

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 2015 (undefined)

Primary Completion Date

November 2020 (Anticipated)

Study Completion Date

November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Persistent Atrial Fibrillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Rhythm control group

Arm Type

Active Comparator

Arm Description

Arm Title

Rate control group

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Propafenone

Intervention Description

AAD(antiarrhythmic drug)

Intervention Type

Drug

Intervention Name(s)

Apixaban

Intervention Description

anti-coagulation

Primary Outcome Measure Information:

Title

K-MOCA(Korean version of Montreal Cognitive Assessment)

Time Frame

12 months after the enrollment

Title

Brain perfusion CT

Time Frame

12 months after the enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hui-Nam Park, MD, Ph.D

Phone

82-2-2228-8459

hnpak@yuhs.ac

Facility Information:

Facility Name

Severance Cardiovascular Hospital, Yonsei University Health System

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

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

Phone

82-2-2228-8459

hnpak@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD

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

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