Transient Ischemic Attack (TIA) Clinical Trials

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Long-term Clinical Outcomes and Prognostic Factors After Percutaneous Patent Foramen Ovale Closure: A Retrospective Cohort Study With Prospective Registry Extension

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Yonsei University College of Medicine
RECRUITING
Seoul
Contact Information
Primary
Jung-Sun Kim, Professor
kjs1218@yuhs.ac
+82-2-2228-8335
Time Frame
Start Date: 2026-06-05
Estimated Completion Date: 2036-05-04
Participants
Target number of participants: 400
Treatments
Retrospective cohort
Patients aged 19 years or older who underwent percutaneous patent foramen ovale closure between 2010 and March 2026 and had at least one post-procedural agitated saline transthoracic echocardiography. Approximately 140 patients. Data are obtained by review of electronic medical records under a waiver of informed consent.
Prospective registry cohort
Group/Cohort Description: Patients aged 19 years or older who undergo percutaneous patent foramen ovale closure after institutional review board approval, provide written informed consent, and are followed prospectively for up to 119 months.
Sponsors
Leads: Yonsei University

This content was sourced from clinicaltrials.gov