Efficacy of Early Rhythm Control Therapy in Patients With Subclinical Atrial Fibrillation

Summary

The goal of this study to find out the efficacy of early rhythm therapy in patients with subclinical atrial fibrillation detected by Cardiac Electronic Implantable Devices.

Early rhythm therapy includes antiarrhythmic drug, cardioversion, and catheter ablation. The general control group receives general management without the above atrial fibrillation rhythm control treatment.

Researchers will compare early rhythm control groups to general control groups to see if early rhythm therapy works to reduce the atrial fibrillation burden by 50% or more, or decrease the incidence of clinical AF documentation.

Participants will:

* Randomly allocated to two groups at a 1:1 ratio.
* Receive the treatment according to their assigned group.
* Visit the clinic once every three months for checkups and tests.

Conditions

• Atrial Fibrillation (AF)
• Diseases of the Circulatory System
• Atrial Flutter

Interventions

DRUG

early rhythm control group

flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone and so on

PROCEDURE

cardioversion, catheter ablation

only when clinical atrial fibrillation (if atrial fibrillation continued for more than 30 seconds on a 12-lead electrocardiogram or holter monitoring) is confirmed

OTHER

general control

General management without atrial fibrillation rhythm control treatment.(Observation without additional medication, or heart rate control treatment if necessary) Heart rate control drugs such as beta-blockers, calcium channel blockers (Non-dihydropyridine CCB), and digoxin are used for heart rate control according to the doctor's prescription.

Sponsors & Collaborators

• Korea University Guro Hospital

  collaborator OTHER

• Korea University Anam Hospital

  collaborator OTHER

• Keimyung University Dongsan Medical Center

  collaborator OTHER

• Sinchon Severance Hospital, Yonsei University College of Medicine

  collaborator UNKNOWN

• Wonju Severance Christian Hospital

  collaborator OTHER

• Asan Medical Center

  collaborator OTHER

• Inje University Ilsan Paik Hospital

  collaborator OTHER

• The Catholic University of Korea

  collaborator OTHER

• Samsung Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-02

Primary Completion

2027-12-15

Completion

2029-12-31

Countries

• South Korea

Study Locations