Long-term results after closing a hole between the heart's upper chambers
Follows people who had patent foramen ovale closure, tracking strokes, shunts and heart rhythm.
Plain-language title generated from the registry record
Registry title: Long-term Outcomes After Percutaneous Patent Foramen Ovale Closure (Severance PFO Registry)
Key facts
- Where
- Seoul, South KoreaSee the site
Where in South Korea
- Yonsei University College of MedicineSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Yonsei University
- Trial code
- NCT07724171
- Record updated
- 23 July 2026
- Original description
Patent foramen ovale (PFO) is a congenital interatrial communication present in about one quarter of the general population and is recognized as a major cause of cryptogenic stroke. Percutaneous PFO closure reduces recurrent stroke, but a residual right-to-left shunt persists in 20 to 40 percent of patients after device implantation. Long-term data on device performance, the evolution of residual shunt over time, new-onset atrial fibrillation and other prognostic factors remain limited.Read full original descriptionShow less
Long-term Clinical Outcomes and Prognostic Factors After Percutaneous Patent Foramen Ovale Closure: A Retrospective Cohort Study With Prospective Registry Extension
Patent foramen ovale (PFO) is a congenital interatrial communication present in about one quarter of the general population and is recognized as a major cause of cryptogenic stroke. Percutaneous PFO closure reduces recurrent stroke, but a residual right-to-left shunt persists in 20 to 40 percent of patients after device implantation. Long-term data on device performance, the evolution of residual shunt over time, new-onset atrial fibrillation and other prognostic factors remain limited.
This single-center registry evaluates the long-term efficacy and safety of percutaneous PFO closure and identifies the clinical, anatomical, procedural and pharmacological factors associated with clinical and echocardiographic outcomes. The registry combines a retrospective cohort of patients treated at Severance Hospital between 2010 and March 2026 with a prospective registry extension that enrolls patients undergoing PFO closure after institutional review board approval, with follow-up for up to 119 months.
Clinical outcomes include recurrent ischemic stroke or transient ischemic attack, all-cause death, device-related complications and new-onset atrial fibrillation. Echocardiographic outcomes are assessed by serial agitated saline transthoracic echocardiography, which allows the presence, grade and longitudinal trajectory of residual shunt to be characterized.
Inclusion: Age 19 years or older; Percutaneous patent foramen ovale closure; Retrospective cohort: closure performed between 2010 and March 2026, with at least one post-procedural agitated saline transthoracic echocardiography; Prospective cohort: closure performed after institutional review board approval, with written informed consent.
Exclusion: Atrial septal defect closure (defect other than patent foramen ovale); Device embolization or device removal; Echocardiographic image quality inadequate for assessment of shunt; Prospective cohort: refusal of informed consent.