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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 89
Healthy Volunteers: f
View:

• Patients who are scheduled to undergo atrial fibrillation catheter ablation due to atrial fibrillation refractory to antiarrhythmic drug treatment.

• Patients with non-gender CHA2DS2-VASc score 1-4.

• 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.

• Patients aged 19-89 (inclusive) who voluntarily sign the informed consent form.

Locations
Other Locations
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Eue-Keun Choi, MD, PhD
choiek17@snu.ac.kr
82-2-2072-0688
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 400
Treatments
Active_comparator: non-interrupted group
Anticoagulation is continued regardless of atrial fibrillation recurrence.
Experimental: PIP anticoagulation group
Anticoagulation continuation will be determined based on the rhythm monitored by ILR. If atrial fibrillation persists more than 6 hours a day, anticoagulation should be started at that point on and continued for four weeks. Anticoagulation can be prescribed even in case of less-than-6-hour cumulative atrial fibrillation burden if the investigator decides that the anticoagulation is necessary.
Related Therapeutic Areas
Sponsors
Collaborators: Samjin Pharmaceutical Co., Ltd., Medtronic Korea Co., Ltd.
Leads: Seoul National University Hospital

This content was sourced from clinicaltrials.gov