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โ† Trials
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The Modified "Pills-in-the-Pocket" Strategy

RecruitingNAAges 18 Years - anyAllYumei Xue
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In plain words

What the trial is, and whether it could suit you

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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria:(1) Age โ‰ฅ18 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 โ‰ฅ50mm 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. \-
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What it tests

  • use Amiodarone, Bisoprolol and Digoxin
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Where

1 site
Guangdong Provincial People's Hospital
Guangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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