Evaluating anticoagulation strategies after atrial fibrillation catheter ablation
Comparison Between Continuous Oral Anticoagulation Versus Pill-in-the-POCKET Oral AntiCoagulation Strategy Guided by Continuous Rhythm Monitoring Using Implantable Loop Recorder After Atrial Fibrillation Catheter Ablation
This study is testing if stopping blood thinners after successful heart procedure for atrial fibrillation is safe and helpful for patients compared to staying on them continuously.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 19 Years to 89 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06216769 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the clinical benefit and safety of a pill-in-the-POCKET anticoagulation strategy following catheter ablation for atrial fibrillation. Participants will be randomized into two groups: one receiving continuous anticoagulation and the other receiving anticoagulation based on atrial fibrillation recurrence confirmed by implantable loop recorders. The goal is to determine if discontinuing anticoagulants after successful ablation is safe and beneficial for patients. The study will involve patients scheduled for catheter ablation who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are patients aged 19-89 scheduled for atrial fibrillation catheter ablation with a CHA2DS2-VASc score of 1-4.
Not a fit: Patients with a history of stroke or significant bleeding disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce unnecessary long-term anticoagulation for patients who achieve sinus rhythm after ablation, potentially lowering the risk of bleeding complications.
How similar studies have performed: Previous observational studies have suggested that anticoagulant discontinuation after successful catheter ablation may be safe, but this study aims to provide more definitive evidence through a randomized approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Eue-Keun Choi, MD, PhD
- Email: choiek17@snu.ac.kr
- Phone: 82-2-2072-0688
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.