Registry of elderly patients with embolic stroke of undetermined source and patent foramen ovale
Prospective Registry of Elderly Patients With ESUS to Evaluate the Role of Covert Atrial Fibrillation and Patent Foramen Ovale
This study is testing if closing a small hole in the heart can help older patients who have had a certain type of stroke feel better compared to just taking standard medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05238610 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are elderly patients over 60 years old diagnosed with ESUS and identified as having a high-risk PFO.
Not a fit: Patients with transient ischemic attacks, significant stenosis, or other specific stroke causes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective stroke prevention strategies for elderly patients with PFO.
How similar studies have performed: Previous studies have shown success in younger populations with PFO closure, but this approach in elderly patients is less established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.