Long-term outcomes after PFO closure at Severance Hospital
Official title: Long-term Clinical Outcomes and Prognostic Factors After Percutaneous Patent Foramen Ovale Closure: A Retrospective Cohort Study With Prospective Registry Extension
Run by Yonsei University · NCT07724171 · Data updated 2026-11-12
This registry tests how well percutaneous PFO closure works over the long term and what factors predict residual shunt, new atrial fibrillation, or other outcomes in adults who had the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | June 5, 2026 |
| Main results expected | May 4, 2036 |
| Study ends | May 4, 2036 |
| Registry record updated | July 23, 2026 |
| Trial ID | NCT07724171 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (19+) who have undergone percutaneous PFO closure at Severance Hospital and have usable echocardiographic data, including retrospective patients and new consented prospective participants.
✕Probably not a fit
Patients without residual shunt or without adverse events during follow-up may experience limited direct benefit, and those who are not eligible or consented may not participate.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an ambispective, single-center registry at Severance Cardiovascular Hospital. It combines retrospective data (2010–March 2026) and a prospective follow-up to up to 119 months to evaluate safety and efficacy of PFO closure. The study collects clinical and imaging data, including agitated saline echocardiography to assess residual shunt over time, and analyzes factors related to outcomes. Enrollment includes patients aged 19+ who underwent closure, with separate retrospective and prospective cohorts and follow-up visits at multiple intervals. The goal is to understand long-term device performance, shunt evolution, and associated prognostic factors.
Why it matters
Potential benefit: If successful, the registry could clarify long-term risks and benefits of PFO closure and help tailor follow-up and decision-making for patients with cryptogenic stroke or related events.
How similar studies have gone: Prior studies have shown reduced recurrent stroke after PFO closure, with concerns about residual shunt and atrial fibrillation; this registry adds long-term, real-world data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 19 years or older 2. Percutaneous patent foramen ovale closure 3. Retrospective cohort: closure performed between 2010 and March 2026, with at least one post-procedural agitated saline transthoracic echocardiography 4. Prospective cohort: closure performed after institutional review board approval, with written informed consent Exclusion Criteria: 1. Atrial septal defect closure (defect other than patent foramen ovale) 2. Device embolization or device removal 3. Echocardiographic image quality inadequate for assessment of shunt 4. Prospective cohort: refusal of informed consent
Where it's running
-
Yonsei University College of Medicine
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Jung-Sun Kim, Professor
- Email: kjs1218@yuhs.ac
- Phone: +82-2-2228-8335
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
P3 Occluder System for closing a heart opening (PFO) after stroke
We are testing the P3 Occluder System to see if it safely and effectively closes a patent foramen ovale in adults who had a stroke related to their heart opening.
-
Percutaneous repair of the atrial septum using the P3 Occluder System for PFO closure
This trial tests the P3 Occluder System to close a patent foramen ovale (PFO) in adults 18–65 who have had a stroke that may be linked to their PFO.
-
Transcatheter closure versus medical therapy for PFO in older adults
This tests whether closing a patent foramen ovale (PFO) with a catheter plus usual medicines prevents another unexplained (cryptogenic) stroke in people over 60 better than medicines alone.
-
Evaluating Cera™ devices for closing heart openings in stroke patients
This study is testing a new device to see if it can safely close heart openings in stroke patients and work as well as other options available.
-
Testing a new device for closing a heart defect related to stroke
This study is testing a new device to close a heart defect in patients who have had a stroke to see if it works as well as other approved devices.
-
Observing patients with BIOTRONIK Implantable Cardiac Monitors
This study looks at how well the BIOMONITOR III and similar heart monitors work and keep patients safe over time.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.