Actively Recruiting
The Modified "Pills-in-the-Pocket" Strategy
Led by Yumei Xue · Updated on 2024-10-24
328
Participants Needed
1
Research Sites
9 weeks
Total Duration
On this page
Sponsors
Y
Yumei Xue
Lead Sponsor
B
Beijing Anzhen Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is 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. Translated with DeepL.com (free version)
CONDITIONS
Official Title
The Modified "Pills-in-the-Pocket" Strategy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Non-valvular, non-paroxysmal atrial fibrillation within 5 years of first diagnosis
- Recurrent atrial arrhythmia lasting more than 24 hours after the first catheter ablation and not self-terminating
- Patients not currently taking antiarrhythmic drugs after the procedure and agreeing to receive them without contraindications, or patients off such drugs for more than 1 month
You will not qualify if you...
- Previous cardiac surgery such as bypass grafting or valve replacement
- Presence of cardiomyopathy (hypertrophic, dilated, ischemic, etc.)
- Left atrium diameter 50mm or greater or valvular changes from rheumatic heart disease
- History of abnormal thyroid function
- Severe liver or kidney failure (eGFR less than 15, Child Class 3) or history of dialysis
- Heart rate below 60 bpm or any degree of atrioventricular block or multiple branch block after catheter ablation
- Left ventricular ejection fraction below 40% or NYHA class III-IV after catheter ablation
- Participation in another drug or device clinical trial during the same period
- Other abnormalities or diseases deemed exclusionary by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
Y
Yumei Xue, phD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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