Pill-in-the-POCKET Oral Anticoagulation Strategy After AF Catheter Ablation
ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-89
SponsorSeoul National University Hospital
About this trial
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
Qualifiers
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.
Disqualifiers
Patients with a stroke/transient ischemic attack history.
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).
Patients who are contraindicated to anticoagulants other than those listed above.
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.
Trial design
Treatments tested in this trial
- Rivaroxaban
Treatment groups
400 Participants
are divided into 2 treatment groupsSponsors and collaborators
Seoul National University Hospital
Lead sponsor
Samjin Pharmaceutical Co., Ltd.
Collaborator
Medtronic
Collaborator
Source ClinicalTrials.gov