RecruitingNot ApplicableNCT06216769

Pill-in-the-POCKET Oral Anticoagulation Strategy After AF 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


Sponsor

Seoul National University Hospital

Enrollment

400 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a "pill-in-the-pocket" anticoagulation (blood thinning) strategy after catheter ablation for atrial fibrillation (AF). Currently, patients typically take blood thinners every day after ablation to prevent stroke. This study tests whether some patients can safely take them only when needed based on monitoring data from a small implanted heart monitor, rather than daily. **You may be eligible if...** - You are 19 to 89 years old - You have AF that has not responded to medication and you are scheduled for catheter ablation - You are currently taking a direct oral anticoagulant (such as rivaroxaban, dabigatran, apixaban, or edoxaban) - Your stroke risk score (CHA2DS2-VASc) is between 1 and 4 - You plan to continue blood thinners long-term to prevent stroke **You may NOT be eligible if...** - You have had a previous stroke or mini-stroke (TIA) - You have a bleeding disorder, significant recent gastrointestinal bleeding, or history of bleeding in the brain or eyes - You have severe anemia or very low platelet counts - You are on dialysis or have severe kidney failure - You have severe liver disease, advanced heart failure (NYHA Class IV), or severe heart valve disease - You have a condition that prevents implanting a small heart monitor under the skin - Your heart arrhythmia is hemodynamically unstable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRivaroxaban

Those in the non-interrupted anticoagulation group, anticoagulation is continued regardless of atrial fibrillation recurrence. Those in the pill-in-the POCKET anticoagulation group will receive direct oral anticoagulation only if they have atrial fibrillation recur over 6 hours.


Locations(1)

Seoul National University Hospital

Seoul, South Korea

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NCT06216769


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