Atrial Fibrillation Trial, Recruiting NCT06216769 Sponsor: Seoul National University Hospital Condition: Atrial Fibrillation
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Atrial Fibrillation Trial, Recruiting

NCT06216769
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are scheduled to have a catheter ablation procedure for atrial fibrillation (an irregular heartbeat) because medication has not worked well enough to control it.
  • People with a stroke risk score (called CHA2DS2-VASc, not counting gender) of between 1 and 4.
  • People who are currently taking one of these blood thinners — rivaroxaban, dabigatran, apixaban, or edoxaban — and plan to continue taking one of them long-term to reduce stroke risk from atrial fibrillation.
  • People aged 19 to 89 years (inclusive) who are willing to voluntarily sign a consent form to participate.

Who may not be able to join:

  • People who have previously had a stroke or a transient ischemic attack (sometimes called a "mini-stroke").
  • People with certain bleeding conditions or diseases that make blood-thinning medication unsafe, including clotting disorders, significant gastrointestinal bleeding within the past 6 months, a history of bleeding in the brain or eye, or who have received clot-dissolving treatment within 48 hours before joining the study.
  • People who have other medical reasons that prevent them from safely taking blood-thinning medication.
  • People whose heart and circulation are unstable at the time of joining, such as those in cardiogenic shock, with a serious heart rhythm problem that has not responded to treatment, or with very severe heart failure (confirm with trial site).
  • People with severely low red blood cell levels (haemoglobin below 8 g/dL) or who have received a blood transfusion within the four weeks before the first visit.
  • People with a very low platelet count (below 50,000/mm³), which affects the blood's ability to clot.
  • People who are on dialysis or who have very severe kidney disease (with a creatinine clearance below 15 ml/min).
  • People with severe liver disease, including conditions such as bleeding from varicose veins in the oesophagus, fluid build-up in the abdomen, confusion caused by liver failure, or jaundice.
  • People for whom implanting a small heart-monitoring device under the skin (called an implantable loop recorder) would not be safe, such as those with a weakened immune system or a condition that affects wound healing.
  • People with severe heart valve disease, an artificial heart valve, a repaired mitral valve, or rheumatic mitral valve narrowing (regardless of how severe it is).
  • People who need to take blood-thinning medication long-term for a reason unrelated to an irregular heartbeat.
  • People who have a condition called hypertrophic cardiomyopathy (a thickening of the heart muscle).
  • People considered to be at high risk of stroke from causes other than the heart, such as significant narrowing of the arteries in the neck (confirm with trial site).
  • People who are currently taking warfarin or coumadin (older types of blood-thinning medication).
  • People who are currently taking two different antiplatelet medications at the same time (confirm with trial site).
  • People who are pregnant, breastfeeding, or women of childbearing age who are not willing to use a reliable form of contraception throughout the study. Acceptable methods listed include condoms, injectable or implantable contraceptives, intrauterine devices, and oral contraceptives.
  • People who have had chemotherapy for a known or suspected cancer within the past year.
  • People who already have a previously implanted heart device or implantable loop recorder.
  • People who have previously had a procedure to close off the left atrial appendage (a small pouch in the heart).
  • People who are currently taking part in another randomised clinical trial and are still in the follow-up period.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 82-2-2072-0688

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 February 2024
Est. completion
31 December 2030

Where this trial is recruiting

🇰🇷 South Korea

Primary endpoints

Composite of ischemic stroke, transient ischemic attack, other systemic embolism, bleeding (major, clinically relevant), all-cause death

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov