RecruitingNot ApplicableNCT06657404

The Modified "Pills-in-the-Pocket" Strategy

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

Sponsor

Yumei Xue

Enrollment

328 participants

Start Date

Oct 23, 2024

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation (AF)

Summary

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. Translated with DeepL.com (free version)

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a modified "pill-in-the-pocket" approach — taking a heart rhythm medication only when a fast, irregular heartbeat (atrial fibrillation) occurs — in people whose irregular heartbeat came back after a catheter ablation procedure. **You may be eligible if...** - You are 18 or older with atrial fibrillation (AF) that returned after a catheter ablation - Your irregular heartbeat episodes last longer than 24 hours and don't stop on their own - You are willing to take a heart rhythm medication when needed **You may NOT be eligible if...** - You have had open heart surgery, a mechanical heart valve, or valve replacement - You have an enlarged heart muscle condition (cardiomyopathy) - Your left atrium (a heart chamber) is significantly enlarged - You have a history of thyroid problems - You have severe liver or kidney disease - Your heart pumps less than 40% of blood per beat, or you have severe heart failure symptoms - You have a very slow heart rate or significant heart block - You are currently in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGuse Amiodarone, Bisoprolol and Digoxin

Amiodarone 200mg tid orally for 1 week, then reduced to 200mg bid orally for another week. The dose of amiodarone will be reduced to 200mg bid orally for 1 week, and then 200mg qd maintenance treatment will be started in the 3rd week of dosing. Bisoprolol 2.5-5mg qd oral treatment, the specific dose is decided by the investigator. Digoxin 0.125mg qd orally.

Locations(1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06657404

Related Trials

Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable

NCT074309565 locations

Left Bundle Branch Area Pacing (LBBAP) PMCF Study

NCT0721739213 locations

Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation

NCT0717542842 locations

Peri-procedural Hydration to Prevent Acute Kidney Injury After Pulsed Field Ablation for Atrial Fibrillation

NCT074908081 location

Left Atrial Imaging Prior to Cardioversion: Leveraging Computed Tomography to Rule Out Thrombus in The Emergency Department (LA CLOTTED)

NCT070024501 location