NCT06216769 Pill-in-the-POCKET Oral Anticoagulation Strategy After AF Catheter Ablation
| NCT ID | NCT06216769 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Seoul National University Hospital |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2024-02-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Patients who are scheduled to undergo atrial fibrillation catheter ablation due to atrial fibrillation refractory to antiarrhythmic drug treatment. 2. Patients with non-gender CHA2DS2-VASc score 1-4. 3. Patients who are taking direct oral anticoagulants (rivaroxaban, dabigatran, apixaban, edoxaban) and further plan taking them life-long to prevent stroke caused by atrial fibrillation. 4. Patients aged 19-89 (inclusive) who voluntarily sign the informed consent form. Exclusion Criteria: 1. Patients with a stroke/transient ischemic attack history. 2. Patients with underlying diseases and bleeding findings contraindicated to anticoagulation (e.g., coagulation disorders, bleeding conditions, significant gastrointestinal bleeding within 6 months of enrollment, history of intracranial/intraocular/nontraumatic bleeding, thrombolysis within 48 hours of study enrollment). 3. Patients who are contraindicated to anticoagulants other than those listed above. 4. Patients who are hemodynamically unstable at the time of study enrollment: cardiogenic shock, treatment-unresponsive ventricular arrhythmia, or congestive heart failure (NYHA class IV) at the time of randomization. 5. Patients with underlying severe anemia (hemoglobin \<8 g/dL at baseline) or a transfusion history within four weeks before visit 1. 6. Patients with underlying severe thrombocytopenia (platelet count \<50,000/mm3) 7. The patient is under dialysis or chronic renal failure (creatinine clearance \<15ml/min) 8. The patient has severe liver disease (variceal bleeding, ascites, hepatic encephalopathy, or jaundice). 9. The patient has a contraindication to the implantation of an implantable loop recorder (ILR) (such as limited immunocompetence or a wound-healing disorder). 10. The patient has severe valvular disease (valvular prosthesis, mitral valve repair; rheumatic mitral stenosis is excluded irrespective of the severity of the disease). 11. The patient has a non-arrhythmic condition necessitating long-term oral anticoagulation. 12. Hypertrophic cardiomyopathy 13. The patient is deemed high risk for non-cardioembolic stroke (i.e. significant carotid artery disease). 14. Patients who are taking warfarin or coumadin. 15. Patients who are taking dual antiplatelet agents. 16. Pregnancy, breastfeeding, or women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study. \* \* Medically acceptable contraceptives include condoms, injectable or implantable contraceptives, intrauterine devices, and oral contraceptives. 17. Known or suspected malignancy with a history of chemotherapy within 1 year. 18. The patient has previously implanted cardiac implantable electronic devices or ILR. 19. Patients with a history of left atrial appendage occlusion or left atrial appendage closure. 20. The patient is participating in another randomized clinical trial and is under follow-up observation.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06216769 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 89 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06216769 currently recruiting?
Yes, NCT06216769 is actively recruiting participants. Contact the research team at choiek17@snu.ac.kr for enrollment information.
Where is the NCT06216769 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06216769 clinical trial?
NCT06216769 is sponsored by Seoul National University Hospital. The trial plans to enroll 400 participants.
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