A new approach to treating atrial fibrillation with medication

The Modified "Pills-in-the-Pocket" Strategy -The Combined Effect of Amiodarone, Bisoprolol and Digoxin in the Treatment of Recurrent Atrial Arrhythmia for Non-Paroxysmal Atrial Fibrillation After Catheter Ablation: A Multicenter, Prospective, Randomized, Open-Label, Blinded Endpoint Clinical Trial

This study is testing whether a new combination of heart medications can help people with recurring atrial fibrillation feel better after their first treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 328 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guangdong Provincial People's Hospital (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06657404 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective, randomized controlled study involves 328 patients with non-paroxysmal atrial fibrillation (AF) who have experienced recurrent atrial arrhythmias after their first catheter ablation. Participants are randomly assigned to either a study group receiving triple antiarrhythmic drugs (AADs) or a control group receiving conventional AADs. The aim is to compare the efficacy and safety of these two treatment regimens in restoring normal sinus rhythm (SR) in patients with recurrent AF. The study seeks to identify an effective medication strategy for managing AF recurrence post-ablation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with non-valvular, non-paroxysmal AF diagnosed within the last five years and experiencing recurrent atrial arrhythmias.

Not a fit: Patients with a history of significant cardiac surgery or certain cardiomyopathies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective medication strategy for patients with recurrent atrial fibrillation after catheter ablation.

How similar studies have performed: Other studies have shown varying degrees of success with similar medication strategies, but this specific approach is novel.

Eligibility 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.

\-

Where this trial is running

Guangzhou, Guangdong

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Yumei Xue, phD

Conditions: Atrial Fibrillation, Atrial fibrillation, AF