Long-term Outcomes After Percutaneous Patent Foramen Ovale Closure (Severance PFO Registry)
Recruiting now
Conditions studied: Patent Foramen Ovale, Cryptogenic Stroke, Transient Ischemic Attack Due to Embolism, Atrial Fibrillation
In brief
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.
Key facts
- Study ID
- NCT07724171
- Run by
- Yonsei University
- People needed
- 400
- Starts
- 2026-06-05
- Expected to finish
- 2036-05-04
- Last updated by the study team
- 2026-07-23
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Yonsei University College of Medicine — Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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