Registry of elderly patients with embolic stroke of undetermined source and patent foramen ovale

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the efficacy of patent foramen ovale (PFO) closure in elderly patients over 60 years old who have experienced an embolic stroke of undetermined source (ESUS). Participants will be monitored using an insertable loop recorder to detect paroxysmal atrial fibrillation, and they will receive either PFO closure combined with standard antiplatelet treatment or standard antiplatelet treatment alone. The study is being conducted across 20 centers in Korea, focusing on patients diagnosed with ESUS within 180 days of onset and confirmed to have a high-risk PFO. The goal is to clarify the potential benefits of PFO closure in this older demographic.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients older than 60 years-old
2. Patients diagnosed as ESUS within 180 days from onset
3. PFO found from TTE or TEE, which attributed to the ischemic stroke
4. Patients or their legal representative agreed to participate

Exclusion Criteria:

1. Patients with transient ischemic attack
2. Patients with ischemic stroke at the vascular territory with significant stenosis
3. Patients with high risk cardioembolic stroke detected from EKG, Holter monitoring or echocardiography
4. Patients with other causes which may cause stroke (i.e. vasculitis, dissection, vasospasm, drug related or Moyamoya disease)
5. Patients with active cancer
6. Patients who need long term anticoagulation
7. Patients who have side effect on antiplatelet treatment
8. Patients with active internal bleeding
9. Patients who refuse to participate

Where it's running

• Asan Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Sun U Kwon, MD. PhD
• Email: sukwon@amc.seoul.kr
• Phone: 82-2-3010-3960

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• PFO closure versus blood thinners to prevent repeat stroke in older adults

  This study will test whether closing a patent foramen ovale or taking direct oral anticoagulants better prevents repeat strokes in adults over 60 with PFO-related embolic stroke.

  Recruiting at 3 sites Taichung Veterans General Hospital · Taichung and 2 other locations · NCT07479147

• AI analysis of ECGs to predict atrial fibrillation risk in ESUS patients with an implantable cardiac monitor.

  This project tests whether an AI tool called SmartECG-AF can use a routine 12-lead ECG to predict which ESUS patients with an implantable cardiac monitor will develop atrial fibrillation.

  Recruiting at 5 sites Inha University Hospital · Ansan and 4 other locations · NCT07347691

• Using a MEMO wearable patch to find atrial fibrillation after an unexplained stroke

  This trial will try a wearable single-lead ECG patch (MEMO Patch) to find previously missed atrial fibrillation in adults who had an embolic stroke of unknown cause.

  Recruiting Asan Medical Center · Seoul, Songpa-gu · NCT07295769

• Left atrial function in people with unexplained (cryptogenic) stroke.

  This will see if lower left atrial strain on a heart ultrasound is linked to unexplained (cryptogenic) stroke and to higher risk of another stroke in adults who had a stroke without a known cause.

  Recruiting University of Pittsburgh · Pittsburgh, Pennsylvania · NCT07224178

• High-coverage carotid stent versus medical treatment to prevent embolism from symptomatic non-stenotic carotid disease (SyNC)

  This trial will test whether placing a high‑coverage carotid stent, compared with medical therapy alone, reduces repeat embolic events in people who recently had symptoms from low‑grade (10–49%) carotid plaques with high‑risk features.

  Recruiting Acandis GmbH · Solingen, North Rhine-Westphalia · NCT07166731

• Investigating the effects of Empagliflozin on heart function after unexplained strokes

  This study is testing if the medication Empagliflozin can help improve heart function and prevent future strokes in people who have had unexplained strokes.

  Recruiting Phase 2/3 University of East Anglia · Cambridge, Cambridgeshire · NCT06715449

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.