Actively Recruiting
Pill-in-the-POCKET Oral Anticoagulation Strategy After AF Catheter Ablation
Led by Seoul National University Hospital · Updated on 2026-05-04
400
Participants Needed
1
Research Sites
360 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Hospital
Lead Sponsor
S
Samjin Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The clinical benefit of pill-in-the-POCKET anticoagulation after atrial fibrillation catheter ablation remains uncertain. We aimed to evaluate the clinical benefit and safety of pill-in-the-POCKET anticoagulation after atrial fibrillation catheter ablation by randomizing into two groups: non-interrupted anticoagulation after the procedure and anticoagulation based on atrial fibrillation recurrence confirmed by implantable loop recorders.
CONDITIONS
Official Title
Pill-in-the-POCKET Oral Anticoagulation Strategy After AF Catheter Ablation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled for atrial fibrillation catheter ablation due to atrial fibrillation not responding to antiarrhythmic drugs
- Patients with a CHA2DS2-VASc score between 1 and 4, excluding gender
- Patients currently taking direct oral anticoagulants (rivaroxaban, dabigatran, apixaban, edoxaban) and planning lifelong use to prevent stroke
- Patients aged 19 to 89 years who voluntarily sign informed consent
You will not qualify if you...
- History of stroke or transient ischemic attack
- Underlying diseases or bleeding conditions that contraindicate anticoagulation, including recent significant gastrointestinal bleeding or intracranial bleeding
- Contraindications to anticoagulants other than those listed
- Hemodynamic instability at enrollment, such as cardiogenic shock, severe arrhythmia, or advanced heart failure (NYHA class IV)
- Severe anemia (hemoglobin less than 8 g/dL) or recent blood transfusion
- Severe thrombocytopenia (platelet count less than 50,000/mm3)
- Dialysis or chronic kidney failure with creatinine clearance less than 15 ml/min
- Severe liver disease with complications like variceal bleeding or hepatic encephalopathy
- Contraindications to implantable loop recorder implantation
- Severe valvular heart disease or previous mitral valve repair
- Non-arrhythmic conditions requiring long-term anticoagulation
- Hypertrophic cardiomyopathy
- High risk for non-cardioembolic stroke such as significant carotid artery disease
- Use of warfarin or coumadin
- Use of dual antiplatelet therapy
- Pregnancy, breastfeeding, or women of childbearing potential not using effective contraception
- Known or suspected cancer with chemotherapy within one year
- Previous implantation of cardiac devices or loop recorders
- History of left atrial appendage closure or occlusion
- Participation in another randomized clinical trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
Research Team
E
Eue-Keun Choi, MD, 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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