The Modified "Pills-in-the-Pocket" Strategy (ABD-AF)

Yumei Xue

Status: Enrolling

Conditions: Atrial Fibrillation (AF)

Treatments: Drug: use Amiodarone, Bisoprolol and Digoxin

Study type: Interventional

Funder types: Other

Identifiers

NCT06657404

202332

Details and patient eligibility

About

This is a multicentre, prospective, randomised controlled study of 328 patients with non-paroxysmal AF (within 5 years of first diagnosis of AF) with recurrent atrial arrhythmias after first catheter ablation, randomly divided in a 1:1 ratio into a study group treated with triple AADs (amiodarone + bisoprolol + digoxin) and a control group treated with conventional AADs (amiodarone + bisoprolol + digoxin). The study group was treated with triple AADs (amiodarone + bisoprolol) and the control group was treated with conventional AADs (amiodarone + bisoprolol) with the aim of comparing the efficacy and safety of the two groups in terms of reversion of SR, which may provide an effective option of pocket drug reversion for patients with recurrence of SR after AF catheter ablation.

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Enrollment: 328 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:(1) Age ≥18 years; (2) Non-valvular, non-paroxysmal AF (within 5 years of the first diagnosis of AF) with recurrent atrial arrhythmia lasting for more than 24 hours after the first catheter ablation and not self-terminating; (3) Patients who are not taking AADs such as amiodarone, dronedarone, propafenone, etc. after the procedure, and who agree to receive AADs without contraindications to AADs; or patients who are taking AADs such as amiodarone, dronedarone, propafenone, etc. after the procedure, but have been off of them for more than 1 month.

Exclusion Criteria:(1) Previous cardiac surgery, such as cardiac bypass grafting, mechanical valve or prosthetic valve replacement; (2) Combined cardiomyopathy (e.g. hypertrophic cardiomyopathy, dilated cardiomyopathy, ischaemic cardiomyopathy, etc.); (3) Cardiac ultrasound suggests that the diameter of the left atrium is ≥50mm or there are valvular changes in rheumatic heart disease; (4) Previous history of abnormal thyroid function; (5) Severe hepatic or renal insufficiency (eGFR <15, Child Class 3), or history of renal dialysis; (6) Heart rate <60 beats/minute, any degree of atrioventricular block, two-branch or three-branch block at the time of resumption of SR after catheter ablation; (7) Left ventricular ejection fraction <40% or New York Heart Association (NYHA) class III-IV after catheter ablation; (8) Participation in a clinical trial of another drug or device during the same period; (9) Abnormalities or diseases that, in the opinion of the investigator, should be excluded from enrolment in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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328 participants in 2 patient groups

experimental group

Experimental group

Description:

use Amiodarone, Bisoprolol and Digoxin

Treatment:

Drug: use Amiodarone, Bisoprolol and Digoxin

control group

Active Comparator group

Description:

use Bisoprolol and Digoxin

Treatment:

Drug: use Amiodarone, Bisoprolol and Digoxin