Long-term Outcomes After Percutaneous Patent Foramen Ovale Closure (Severance PFO Registry)

NCT07724171 | Recruiting

• 1 other identifier: 4-2026-0496
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Patent Foramen Ovale; Cryptogenic Stroke; Transient Ischemic Attack Due to Embolism; Atrial Fibrillation

Keywords

patent foramen ovale (PFO); percutaneous closure; residual shunt; right-to-left shunt; agitated saline contrast echocardiography; transthoracic echocardiography (TTE); recurrent stroke; transient ischemic attack (TIA); registry; prognostic factors

Outcome Measures

Primary Outcomes (2)

• Number of participants with recurrent ischemic stroke or transient ischemic attack

  First recurrent ischemic stroke or transient ischemic attack after closure, identified from medical records and classified by event type and TOAST criteria. Reported as the number of participants with an event and as the event rate per 100 patient-years.

  From patent foramen ovale closure to the last clinical follow-up: up to 16 years in the retrospective cohort and up to 119 months in the prospective cohort

• Number of participants with residual right-to-left shunt on agitated saline transthoracic echocardiography, by shunt grade

  Residual right-to-left shunt is defined as the appearance of microbubbles in the left heart within three cardiac cycles after right atrial opacification. Shunt grade is assigned from the maximum microbubble count: small (1 to 10), moderate (11 to 30) or large (more than 30). Reported as the number of participants in each grade.

  From patent foramen ovale closure to the last follow-up echocardiography: up to 16 years in the retrospective cohort and up to 119 months in the prospective cohort

Secondary Outcomes (8)

• Number of participants who die from any cause

  From patent foramen ovale closure to the last follow-up: up to 16 years in the retrospective cohort and up to 119 months in the prospective cohort

• Number of participants with device-related complications

  From patent foramen ovale closure to the last follow-up: up to 16 years in the retrospective cohort and up to 119 months in the prospective cohort

• Number of participants with new-onset atrial fibrillation

  From patent foramen ovale closure to the last follow-up: up to 16 years in the retrospective cohort and up to 119 months in the prospective cohort

• Number of participants with the composite of recurrent ischemic stroke or transient ischemic attack, all-cause death, or device-related complications

  From patent foramen ovale closure to the last follow-up: up to 16 years in the retrospective cohort and up to 119 months in the prospective cohort

• Longitudinal pattern of residual shunt on serial agitated saline transthoracic echocardiography

  From patent foramen ovale closure to the last follow-up: up to 16 years in the retrospective cohort and up to 119 months in the prospective cohort

Study Arms (2)

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adults who underwent percutaneous patent foramen ovale closure at a single tertiary referral center in Seoul, Republic of Korea. The retrospective cohort comprises patients treated between 2010 and March 2026 who had at least one post-procedural agitated saline transthoracic echocardiography. The prospective cohort comprises patients undergoing closure after institutional review board approval who provide written informed consent. The population reflects routine clinical practice, and treatment is not assigned by protocol.

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

Related Publications (7)

• Saver JL, Carroll JD, Thaler DE, Smalling RW, MacDonald LA, Marks DS, Tirschwell DL; RESPECT Investigators. Long-Term Outcomes of Patent Foramen Ovale Closure or Medical Therapy after Stroke. N Engl J Med. 2017 Sep 14;377(11):1022-1032. doi: 10.1056/NEJMoa1610057.

  PMID: 28902590 BACKGROUND

• Sondergaard L, Kasner SE, Rhodes JF, Andersen G, Iversen HK, Nielsen-Kudsk JE, Settergren M, Sjostrand C, Roine RO, Hildick-Smith D, Spence JD, Thomassen L; Gore REDUCE Clinical Study Investigators. Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke. N Engl J Med. 2017 Sep 14;377(11):1033-1042. doi: 10.1056/NEJMoa1707404.

  PMID: 28902580 BACKGROUND

• Mas JL, Derumeaux G, Guillon B, Massardier E, Hosseini H, Mechtouff L, Arquizan C, Bejot Y, Vuillier F, Detante O, Guidoux C, Canaple S, Vaduva C, Dequatre-Ponchelle N, Sibon I, Garnier P, Ferrier A, Timsit S, Robinet-Borgomano E, Sablot D, Lacour JC, Zuber M, Favrole P, Pinel JF, Apoil M, Reiner P, Lefebvre C, Guerin P, Piot C, Rossi R, Dubois-Rande JL, Eicher JC, Meneveau N, Lusson JR, Bertrand B, Schleich JM, Godart F, Thambo JB, Leborgne L, Michel P, Pierard L, Turc G, Barthelet M, Charles-Nelson A, Weimar C, Moulin T, Juliard JM, Chatellier G; CLOSE Investigators. Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke. N Engl J Med. 2017 Sep 14;377(11):1011-1021. doi: 10.1056/NEJMoa1705915.

  PMID: 28902593 BACKGROUND

• Lee PH, Song JK, Kim JS, Heo R, Lee S, Kim DH, Song JM, Kang DH, Kwon SU, Kang DW, Lee D, Kwon HS, Yun SC, Sun BJ, Park JH, Lee JH, Jeong HS, Song HJ, Kim J, Park SJ. Cryptogenic Stroke and High-Risk Patent Foramen Ovale: The DEFENSE-PFO Trial. J Am Coll Cardiol. 2018 May 22;71(20):2335-2342. doi: 10.1016/j.jacc.2018.02.046. Epub 2018 Mar 12.

  PMID: 29544871 BACKGROUND

• Deng W, Yin S, McMullin D, Inglessis-Azuaje I, Elmariah S, Hung J, Lo EH, Palacios IF, Buonanno FS, Ning M. Residual Shunt After Patent Foramen Ovale Closure and Long-Term Stroke Recurrence: A Prospective Cohort Study. Ann Intern Med. 2020 Jun 2;172(11):717-725. doi: 10.7326/M19-3583. Epub 2020 May 12.

  PMID: 32422058 BACKGROUND

• Witte LS, El Bouziani A, Beijk MAM, Robbers-Visser D, Coutinho JM, Tijssen JGP, Straver B, Bouma BJ, de Winter RJ. Persistence of residual shunt at 6 and 12 months after transoesophageal echocardiography-guided percutaneous closure of a patent foramen ovale for cryptogenic stroke. Heart. 2024 Sep 16;110(19):1172-1179. doi: 10.1136/heartjnl-2024-323905.

  PMID: 39122559 BACKGROUND

• Ujka K, Pizzuto A, Giordano M, Di Muro FM, Gaio G, Russo MG, Sarubbi B, Meucci F, Santoro G. Prevalence, classification, and treatment of residual shunt after patent foramen ovale closure. EuroIntervention. 2025 Aug 18;21(16):933-941. doi: 10.4244/EIJ-D-24-00856.

  PMID: 40828307 BACKGROUND

MeSH Terms

Conditions

Foramen Ovale, Patent; Ischemic Stroke; Atrial Fibrillation; Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Ischemia

Central Study Contacts

Jung-Sun Kim, Professor

CONTACT

+82-2-2228-8335; kjs1218@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 23, 2026
• Study Start: June 5, 2026
• Primary Completion (Estimated): May 4, 2036
• Study Completion (Estimated): May 4, 2036
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)