Atrial FibrillationPOCKET-OACNCT06216769
Pill-in-the-POCKET Oral Anticoagulation Strategy After AF Catheter Ablation
A study testing Rivaroxaban in people with Atrial Fibrillation, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 89 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Rivaroxaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2024to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Patients with underlying severe anemia (hemoglobin <8 g/dL at baseline) or a transfusion history within four weeks before visit 1.
- Patients with underlying severe thrombocytopenia (platelet count <50,000/mm3)
Show all 21Show fewer
- The patient is under dialysis or chronic renal failure (creatinine clearance <15ml/min)
- The patient has severe liver disease (variceal bleeding, ascites, hepatic encephalopathy, or jaundice).
- The patient has a contraindication to the implantation of an implantable loop recorder (ILR) (such as limited immunocompetence or a wound-healing disorder).
- The patient has severe valvular disease (valvular prosthesis, mitral valve repair; rheumatic mitral stenosis is excluded irrespective of the severity of the disease).
- The patient has a non-arrhythmic condition necessitating long-term oral anticoagulation.
- Hypertrophic cardiomyopathy
- The patient is deemed high risk for non-cardioembolic stroke (i.e. significant carotid artery disease).
- Patients who are taking warfarin or coumadin.
- Patients who are taking dual antiplatelet agents.
- 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.
- Known or suspected malignancy with a history of chemotherapy within 1 year.
- The patient has previously implanted cardiac implantable electronic devices or ILR.
- Patients with a history of left atrial appendage occlusion or left atrial appendage closure.
- The patient is participating in another randomized clinical trial and is under follow-up observation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Eue-Keun Choi, MD, PhD, choiek17@snu.ac.kr
About this study
Official title: 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
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.
Read the detailed description
Atrial fibrillation significantly increases the risk of thromboembolic complications, including stroke. Accordingly, current atrial fibrillation treatment guidelines recommend lifelong prescription of anticoagulants if the CHA2DS2-VASc score is 2 (for males) or 3 (for females) or higher (Class IA). With the recent advances in rhythm control treatment through catheter ablation in atrial fibrillation patients, increasing concerns are being raised about the need to continue anticoagulation after successful catheter ablation. However, current guidelines still require continued anticoagulation based on the baseline CHA2DS2-VASc score regardless of sinus conversion after atrial fibrillation catheter ablation.
A recently published observational study demonstrated that the risk of stroke was reduced by less than 0.7% per year in patients who discontinued anticoagulants after successful catheter ablation. Subsequent meta-analysis studies similarly suggested that anticoagulant discontinuation could be safe in patients whose rhythm was restored to sinus rhythm through catheter ablation. In addition, it was confirmed that anticoagulant discontinuation after catheter ablation was associated with only a 0.6% increase in the risk of thromboembolism as opposed to a 1.8% decrease in the risk of severe bleeding, such as intracranial hemorrhage and respiratory bleeding. Similar findings were also confirmed from large-scale non-randomized studies. However, there is still a lack of large-scale randomized study findings to support that anticoagulant discontinuation is appropriate in atrial fibrillation who are successful converted to sinus rhythm after catheter ablation.
Two single-arm pilot studies have been published about pill-in-the-pocket (PIP) anticoagulation. One is the REACT.COM (Rhythm Evaluation for Anticoagulation With Continuous Monitoring), and the other is the TACTIC-AF (Tailored Anticoagulation for Non-Continuous Atrial Fibrillation). In the above studies, continuous remote monitoring was performed using insertable cardiac monitors, dual-chamber pacemakers, or defibrillators. If atrial fibrillation persisted over a certain period during monitoring, anticoagulation was resumed for 30 days. This approach reduced the use of anticoagulants by 94% in the REACT.COM by resuming anticoagulation when atrial fibrillation recurrence persisted longer than 1 hour. TACTIC-AF observed a 75% reduction in time on anticoagulation using a threshold of 6 minutes or total burden >6 h/d.
Conventionally, recurrence of atrial fibrillation has been confirmed through 12-lead electrocardiogram (ECG) or adhesive 24-hour (or 3-day, 7-day, 2-week) ECG monitoring. However, these methods are limited by the inability to continuously assess the exact atrial fibrillation burden during the follow-up period. As an alternative to this, implantable loop recorders (ILR) enabled with continuous heart rhythm monitoring have recently been widely used in clinical practice. These implantable loop recorders have shown desirable performance in measuring atrial fibrillation recurrence and burden. However, few studies have evaluated the role of continuous rhythm monitoring in guiding OAC in patients with AF.
This study is aimed to evaluate clinical benefits, including the appropriateness, efficacy, and safety of pill-in-the-POCKET anticoagulation, and establish its cost-effectiveness by comparing the incidence of major clinical events after randomization of atrial fibrillation patients scheduled to undergo catheter ablation into two groups: non-interrupted anticoagulation after the procedure and resumed anticoagulation based on atrial fibrillation recurrence confirmed by implantable loop recorders.
- Conditions
- Atrial Fibrillation
- Being tested
- Rivaroxaban
- Keywords
- atrial fibrillation, direct oral anticoagulant, catheter ablation, implantable loop recorder, continuous cardiac rhythm monitor
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| non-interrupted group | Active comparator | Anticoagulation is continued regardless of atrial fibrillation recurrence. Receives: Drug: Rivaroxaban |
| PIP anticoagulation group | Experimental | 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. Receives: Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of ischemic stroke, transient ischemic attack, other systemic embolism, bleeding (major, clinically relevant), all-cause death
Measured: up to 24 months
Secondary outcomes (12)
Composite of thromboembolic events (ischemic stroke, transient ischemic attack, systemic embolism)
Measured: up to 24 months
Composite of bleeding events events (major bleeding and clinically relevant non-major bleeding)
Measured: up to 24 months
Individual components of the primary endpoint.
Any ischemic stroke, any transient ischemic attack, any systemic embolism, any major bleeding, any clinically relevant non-major bleeding, any death
Measured: up to 24 months
Number of Participants with Myocardial Infarction
Measured: up to 24 months
Number of Participants with Cardiovascular Death
Measured: up to 24 months
Number of Participants with Minor Bleeding
Any bleeding that is not major bleeding or clinically relevant non-major bleeding
Measured: up to 24 months
All bleeding (major, clinically relevant non-major bleeding, and minor bleeding)
Measured: up to 24 months
Recurrence of any atrial arrhythmia lasting longer than 2 minutes (atrial arrhythmia: atrial fibrillation/atrial tachycardia)
Measured: up to 24 months
Atrial arrhythmia burden (%) between 3 and 24 months after catheter ablation
Measured: up to 24 months
Quality of Life scores assessed by Atrial Fibrillation Effect on QualiTy-of-life(AFEQT) questionnaire at baseline (preoperative) and at the end of 24 months, respectively
Measured: up to 24 months
Cognitive function assessed by Korea-Montreal Cognitive Assessment (K-MoCA) score questionnaire at baseline (preoperative) and at the end of 24 months, respectively
Measured: up to 24 months
Change in treatment according to ILR results
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Feb 2024
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samjin Pharmaceutical Co., Ltd., Medtronic
- Responsible party
- Principal investigator, Eue-Keun Choi, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216769
- Sponsor's protocol ID
- POCKET-OAC
- Acronym
- POCKET-OAC
- Status last verified
- Apr 2026
- First submitted
- 11 Jan 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Passman R, Leong-Sit P, Andrei AC, Huskin A, Tomson TT, Bernstein R, Ellis E, Waks JW, Zimetbaum P. Targeted Anticoagulation for Atrial Fibrillation Guided by Continuous Rhythm Assessment With an Insertable Cardiac Monitor: The Rhythm Evaluation for Anticoagulation With Continuous Monitoring (REACT.COM) Pilot Study. J Cardiovasc Electrophysiol. 2016 Mar;27(3):264-70. doi: 10.1111/jce.12864. Epub 2015 Nov 23.
PubMed 26511221Waks JW, Passman RS, Matos J, Reynolds M, Thosani A, Mela T, Pederson D, Glotzer TV, Zimetbaum P. Intermittent anticoagulation guided by continuous atrial fibrillation burden monitoring using dual-chamber pacemakers and implantable cardioverter-defibrillators: Results from the Tailored Anticoagulation for Non-Continuous Atrial Fibrillation (TACTIC-AF) pilot study. Heart Rhythm. 2018 Nov;15(11):1601-1607. doi: 10.1016/j.hrthm.2018.06.027. Epub 2018 Jul 6.
PubMed 29981863Hindricks G, Pokushalov E, Urban L, Taborsky M, Kuck KH, Lebedev D, Rieger G, Purerfellner H; XPECT Trial Investigators. Performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation: Results of the XPECT trial. Circ Arrhythm Electrophysiol. 2010 Apr;3(2):141-7. doi: 10.1161/CIRCEP.109.877852. Epub 2010 Feb 16.
PubMed 20160169Karasoy D, Gislason GH, Hansen J, Johannessen A, Kober L, Hvidtfeldt M, Ozcan C, Torp-Pedersen C, Hansen ML. Oral anticoagulation therapy after radiofrequency ablation of atrial fibrillation and the risk of thromboembolism and serious bleeding: long-term follow-up in nationwide cohort of Denmark. Eur Heart J. 2015 Feb 1;36(5):307-14a. doi: 10.1093/eurheartj/ehu421. Epub 2014 Nov 3.
PubMed 25368205Themistoclakis S, Corrado A, Marchlinski FE, Jais P, Zado E, Rossillo A, Di Biase L, Schweikert RA, Saliba WI, Horton R, Mohanty P, Patel D, Burkhardt DJ, Wazni OM, Bonso A, Callans DJ, Haissaguerre M, Raviele A, Natale A. The risk of thromboembolism and need for oral anticoagulation after successful atrial fibrillation ablation. J Am Coll Cardiol. 2010 Feb 23;55(8):735-43. doi: 10.1016/j.jacc.2009.11.039.
PubMed 20170810
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06216769
- Acronym / sponsor ID
- POCKET-OAC / POCKET-OAC
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, direct oral anticoagulant, catheter ablation, implantable loop recorder, continuous cardiac rhythm monitor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Samjin Pharmaceutical Co., Ltd., Medtronic
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Atrial fibrillation significantly increases the risk of thromboembolic complications, including stroke. Accordingly, current atrial fibrillation treatment guidelines recommend lifelong prescription of anticoagulants if the CHA2DS2-VASc score is 2 (for males) or 3 (for females) or higher (Class IA). With the recent advances in rhythm control treatment through catheter ablation in atrial fibrillation patients, increasing concerns are being raised about the need to continue anticoagulation after successful catheter ablation. However, current guidelines still require continued anticoagulation based on the baseline CHA2DS2-VASc score regardless of sinus conversion after atrial fibrillation catheter ablation.
A recently published observational study demonstrated that the risk of stroke was reduced by less than 0.7% per year in patients who discontinued anticoagulants after successful catheter ablation. Subsequent meta-analysis studies similarly suggested that anticoagulant discontinuation could be safe in patients whose rhythm was restored to sinus rhythm through catheter ablation. In addition, it was confirmed that anticoagulant discontinuation after catheter ablation was associated with only a 0.6% increase in the risk of thromboembolism as opposed to a 1.8% decrease in the risk of severe bleeding, such as intracranial hemorrhage and respiratory bleeding. Similar findings were also confirmed from large-scale non-randomized studies. However, there is still a lack of large-scale randomized study findings to support that anticoagulant discontinuation is appropriate in atrial fibrillation who are successful converted to sinus rhythm after catheter ablation.
Two single-arm pilot studies have been published about pill-in-the-pocket (PIP) anticoagulation. One is the REACT.COM (Rhythm Evaluation for Anticoagulation With Continuous Monitoring), and the other is the TACTIC-AF (Tailored Anticoagulation for Non-Continuous Atrial Fibrillation). In the above studies, continuous remote monitoring was performed using insertable cardiac monitors, dual-chamber pacemakers, or defibrillators. If atrial fibrillation persisted over a certain period during monitoring, anticoagulation was resumed for 30 days. This approach reduced the use of anticoagulants by 94% in the REACT.COM by resuming anticoagulation when atrial fibrillation recurrence persisted longer than 1 hour. TACTIC-AF observed a 75% reduction in time on anticoagulation using a threshold of 6 minutes or total burden >6 h/d.
Conventionally, recurrence of atrial fibrillation has been confirmed through 12-lead electrocardiogram (ECG) or adhesive 24-hour (or 3-day, 7-day, 2-week) ECG monitoring. However, these methods are limited by the inability to continuously assess the exact atrial fibrillation burden during the follow-up period. As an alternative to this, implantable loop recorders (ILR) enabled with continuous heart rhythm monitoring have recently been widely used in clinical practice. These implantable loop recorders have shown desirable performance in measuring atrial fibrillation recurrence and burden. However, few studies have evaluated the role of continuous rhythm monitoring in guiding OAC in patients with AF.
This study is aimed to evaluate clinical benefits, including the appropriateness, efficacy, and safety of pill-in-the-POCKET anticoagulation, and establish its cost-effectiveness by comparing the incidence of major clinical events after randomization of atrial fibrillation patients scheduled to undergo catheter ablation into two groups: non-interrupted anticoagulation after the procedure and resumed anticoagulation based on atrial fibrillation recurrence confirmed by implantable loop recorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-interrupted group | Active comparator | Drug: RivaroxabanAnticoagulation is continued regardless of atrial fibrillation recurrence. |
| PIP anticoagulation group | Experimental | Drug: RivaroxabanAnticoagulation 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. |
Who may qualify
- Ages
- 19 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
- Patients with underlying severe anemia (hemoglobin <8 g/dL at baseline) or a transfusion history within four weeks before visit 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RivaroxabanThose 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. | Drug | PIP anticoagulation group, non-interrupted group |
Primary outcome
Composite of ischemic stroke, transient ischemic attack, other systemic embolism, bleeding (major, clinically relevant), all-cause death
Time frame: up to 24 months
12 secondary outcomes
Composite of thromboembolic events (ischemic stroke, transient ischemic attack, systemic embolism)
Time frame: up to 24 months
Composite of bleeding events events (major bleeding and clinically relevant non-major bleeding)
Time frame: up to 24 months
Individual components of the primary endpoint.
Time frame: up to 24 months
Number of Participants with Myocardial Infarction
Time frame: up to 24 months
Number of Participants with Cardiovascular Death
Time frame: up to 24 months
Number of Participants with Minor Bleeding
Time frame: up to 24 months
All bleeding (major, clinically relevant non-major bleeding, and minor bleeding)
Time frame: up to 24 months
Recurrence of any atrial arrhythmia lasting longer than 2 minutes (atrial arrhythmia: atrial fibrillation/atrial tachycardia)
Time frame: up to 24 months
Atrial arrhythmia burden (%) between 3 and 24 months after catheter ablation
Time frame: up to 24 months
Quality of Life scores assessed by Atrial Fibrillation Effect on QualiTy-of-life(AFEQT) questionnaire at baseline (preoperative) and at the end of 24 months, respectively
Time frame: up to 24 months
Cognitive function assessed by Korea-Montreal Cognitive Assessment (K-MoCA) score questionnaire at baseline (preoperative) and at the end of 24 months, respectively
Time frame: up to 24 months
Change in treatment according to ILR results
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 26511221Passman R, Leong-Sit P, Andrei AC, Huskin A, Tomson TT, Bernstein R, Ellis E, Waks JW, Zimetbaum P. Targeted Anticoagulation for Atrial Fibrillation Guided by Continuous Rhythm Assessment With an Insertable Cardiac Monitor: The Rhythm Evaluation for Anticoagulation With Continuous Monitoring (REACT.COM) Pilot Study. J Cardiovasc Electrophysiol. 2016 Mar;27(3):264-70. doi: 10.1111/jce.12864. Epub 2015 Nov 23.
- Background: PubMed 29981863Waks JW, Passman RS, Matos J, Reynolds M, Thosani A, Mela T, Pederson D, Glotzer TV, Zimetbaum P. Intermittent anticoagulation guided by continuous atrial fibrillation burden monitoring using dual-chamber pacemakers and implantable cardioverter-defibrillators: Results from the Tailored Anticoagulation for Non-Continuous Atrial Fibrillation (TACTIC-AF) pilot study. Heart Rhythm. 2018 Nov;15(11):1601-1607. doi: 10.1016/j.hrthm.2018.06.027. Epub 2018 Jul 6.
- Background: PubMed 20160169Hindricks G, Pokushalov E, Urban L, Taborsky M, Kuck KH, Lebedev D, Rieger G, Purerfellner H; XPECT Trial Investigators. Performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation: Results of the XPECT trial. Circ Arrhythm Electrophysiol. 2010 Apr;3(2):141-7. doi: 10.1161/CIRCEP.109.877852. Epub 2010 Feb 16.
- Background: PubMed 25368205Karasoy D, Gislason GH, Hansen J, Johannessen A, Kober L, Hvidtfeldt M, Ozcan C, Torp-Pedersen C, Hansen ML. Oral anticoagulation therapy after radiofrequency ablation of atrial fibrillation and the risk of thromboembolism and serious bleeding: long-term follow-up in nationwide cohort of Denmark. Eur Heart J. 2015 Feb 1;36(5):307-14a. doi: 10.1093/eurheartj/ehu421. Epub 2014 Nov 3.
- Background: PubMed 20170810Themistoclakis S, Corrado A, Marchlinski FE, Jais P, Zado E, Rossillo A, Di Biase L, Schweikert RA, Saliba WI, Horton R, Mohanty P, Patel D, Burkhardt DJ, Wazni OM, Bonso A, Callans DJ, Haissaguerre M, Raviele A, Natale A. The risk of thromboembolism and need for oral anticoagulation after successful atrial fibrillation ablation. J Am Coll Cardiol. 2010 Feb 23;55(8):735-43. doi: 10.1016/j.jacc.2009.11.039.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rivaroxaban in people with Atrial Fibrillation, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eue-Keun Choi, MD, PhD (82-2-2072-0688, choiek17@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of ischemic stroke, transient ischemic attack, other systemic embolism, bleeding (major, clinically relevant), all-cause death (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06216769, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.