NCT07724171 Long-term Outcomes After Percutaneous Patent Foramen Ovale Closure (Severance PFO Registry)
| NCT ID | NCT07724171 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yonsei University |
| Condition | Patent Foramen Ovale |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2026-06-05 |
| Primary Completion | 2036-05-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2026-06-05 with a primary completion date of 2036-05-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07724171 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Patent Foramen Ovale. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07724171 currently recruiting?
Yes, NCT07724171 is actively recruiting participants. Contact the research team at kjs1218@yuhs.ac for enrollment information.
Where is the NCT07724171 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07724171 clinical trial?
NCT07724171 is sponsored by Yonsei University. The trial plans to enroll 400 participants.