Patent Foramen OvaleNCT07724171
Long-term Outcomes After Percutaneous Patent Foramen Ovale Closure (Severance PFO Registry)
An observational study of Patent Foramen Ovale and Cryptogenic Stroke, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Patent Foramen Ovale, Cryptogenic Stroke, Transient Ischemic Attack Due to Embolism
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jun 2026to 4 May 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University College of Medicine
Seoul
Jung-Sun Kim, Professor, +82-2-2228-8335, kjs1218@yuhs.ac
About this study
Official title: 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.
Read the detailed description
Design: ambispective observational registry conducted at Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
Part A (retrospective cohort): consecutive patients aged 19 years or older who underwent percutaneous PFO closure between 2010 and March 2026 and had at least one post-procedural agitated saline transthoracic echocardiography. Data are collected by direct review of electronic medical records, with the data cut-off set at the date of institutional review board approval. The requirement for informed consent is waived for this part.
The retrospective component comprises approximately 140 patients who underwent closure between 2010 and March 2026. A subgroup of these patients underwent two or more serial agitated saline transthoracic echocardiography examinations and is analyzed for the longitudinal trajectory of residual shunt.
Part B (prospective registry extension): patients aged 19 years or older who undergo percutaneous PFO closure after institutional review board approval and provide written informed consent. Follow-up visits are scheduled at 6, 12, 24, 48, 72, 96 and 119 months. Agitated saline transthoracic echocardiography is performed 6 months after closure and repeated at subsequent follow-up visits as clinically indicated.
Data collected: demographics and body mass index, smoking status, comorbidities (hypertension, diabetes mellitus, dyslipidemia, atrial fibrillation, coronary artery disease, deep vein thrombosis, pulmonary embolism, hypercoagulable state), index event characteristics (stroke or transient ischemic attack type, TOAST classification, brain imaging, Risk of Paradoxical Embolism score), echocardiographic and anatomical variables (atrial septal aneurysm and excursion distance, septal hypermobility, PFO tunnel length, PFO opening size, Eustachian valve, Chiari network, left ventricular ejection fraction), procedural variables (device type and size, guidance modality, balloon sizing, procedure time, fluoroscopy time, procedural complications), antithrombotic therapy, serial agitated saline transthoracic echocardiography results, clinical events and modified Rankin Scale.
Agitated saline transthoracic echocardiography: 9 mL of normal saline mixed with 1 mL of air is agitated between two syringes and injected through an antecubital vein at rest and during the Valsalva maneuver. A study is positive when microbubbles appear in the left heart within three cardiac cycles after right atrial opacification. Shunt grade is assigned from the maximum number of microbubbles in the left heart within three cardiac cycles: small (1 to 10), moderate (11 to 30) or large (more than 30), in accordance with American Society of Echocardiography guidance. In patients with two or more serial examinations, the sequence of positive and negative results over time is recorded and the longitudinal pattern of residual shunt is classified.
Statistical analysis: continuous variables are summarized as mean with standard deviation or median with interquartile range, and categorical variables as frequency and percentage. Cumulative event rates are estimated by the Kaplan-Meier method and compared with the log-rank test. Cox proportional hazards models are used to estimate hazard ratios with 95 percent confidence intervals. Predictors of residual shunt are examined by logistic regression. Analyses are performed with R version 4.0 or later, and a two-sided p value below 0.05 is considered statistically significant.
- 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
- Medical subject headings
- Foramen Ovale, Patent, Ischemic Stroke, Atrial Fibrillation, Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Death from any cause, ascertained from medical records.
Measured: 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
Device embolization, device thrombus, erosion, reintervention or surgical device removal.
Measured: 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
Atrial fibrillation newly documented on electrocardiography, Holter monitoring or event recorder, classified as paroxysmal, persistent or permanent.
Measured: 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
Composite of recurrent ischemic stroke or transient ischemic attack, all-cause death, and device-related complications, analyzed as time to first event.
Measured: 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
Among participants with two or more serial agitated saline transthoracic echocardiography studies, the sequence of positive and negative results over time is recorded and the longitudinal pattern of residual shunt is classified.
Measured: 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
Time to spontaneous resolution of residual shunt
Interval from the first positive to the first negative agitated saline transthoracic echocardiography, estimated by the Kaplan-Meier method.
Measured: 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
Predictors of residual right-to-left shunt on agitated saline transthoracic echocardiography
Measure: adjusted odds ratio with 95% confidence interval for the presence of residual right-to-left shunt, defined as microbubbles in the left heart within three cardiac cycles after right atrial opacification on agitated saline transthoracic echocardiography. Measurement tool: multivariable logistic regression model. Unit of measure: odds ratio. Candidate variables entered into the model include device type, device size, right atrial disc diameter, patent foramen ovale tunnel length, patent foramen ovale opening size, atrial septal aneurysm, septal hypermobility, imaging guidance modality (transesophageal or intracardiac echocardiography) and use of balloon sizing.
Measured: 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
Functional status measured with the modified Rankin Scale
Modified Rankin Scale score at follow-up, ranging from 0 (no symptoms) to 6 (death); higher scores indicate greater disability.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start5 Jun 2026
- Primary completion4 May 2036 (estimated)
- Study completion4 May 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Patent Foramen OvaleStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724171
- Sponsor's protocol ID
- 4-2026-0496
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared.
Publications
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.
PubMed 28902590Sondergaard 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.
PubMed 28902580Mas 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.
PubMed 28902593Lee 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.
PubMed 29544871Deng 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.
PubMed 32422058Witte 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.
PubMed 39122559Ujka 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.
PubMed 40828307
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Clinical Outcomes and Prognostic Factors After Percutaneous Patent Foramen Ovale Closure: A Retrospective Cohort Study With Prospective Registry Extension
- ClinicalTrials.gov ID
- NCT07724171
- Acronym / sponsor ID
- 4-2026-0496
- 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)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- 4 May 2036 (estimated)
- Study completion
- 4 May 2036 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Design: ambispective observational registry conducted at Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
Part A (retrospective cohort): consecutive patients aged 19 years or older who underwent percutaneous PFO closure between 2010 and March 2026 and had at least one post-procedural agitated saline transthoracic echocardiography. Data are collected by direct review of electronic medical records, with the data cut-off set at the date of institutional review board approval. The requirement for informed consent is waived for this part.
The retrospective component comprises approximately 140 patients who underwent closure between 2010 and March 2026. A subgroup of these patients underwent two or more serial agitated saline transthoracic echocardiography examinations and is analyzed for the longitudinal trajectory of residual shunt.
Part B (prospective registry extension): patients aged 19 years or older who undergo percutaneous PFO closure after institutional review board approval and provide written informed consent. Follow-up visits are scheduled at 6, 12, 24, 48, 72, 96 and 119 months. Agitated saline transthoracic echocardiography is performed 6 months after closure and repeated at subsequent follow-up visits as clinically indicated.
Data collected: demographics and body mass index, smoking status, comorbidities (hypertension, diabetes mellitus, dyslipidemia, atrial fibrillation, coronary artery disease, deep vein thrombosis, pulmonary embolism, hypercoagulable state), index event characteristics (stroke or transient ischemic attack type, TOAST classification, brain imaging, Risk of Paradoxical Embolism score), echocardiographic and anatomical variables (atrial septal aneurysm and excursion distance, septal hypermobility, PFO tunnel length, PFO opening size, Eustachian valve, Chiari network, left ventricular ejection fraction), procedural variables (device type and size, guidance modality, balloon sizing, procedure time, fluoroscopy time, procedural complications), antithrombotic therapy, serial agitated saline transthoracic echocardiography results, clinical events and modified Rankin Scale.
Agitated saline transthoracic echocardiography: 9 mL of normal saline mixed with 1 mL of air is agitated between two syringes and injected through an antecubital vein at rest and during the Valsalva maneuver. A study is positive when microbubbles appear in the left heart within three cardiac cycles after right atrial opacification. Shunt grade is assigned from the maximum number of microbubbles in the left heart within three cardiac cycles: small (1 to 10), moderate (11 to 30) or large (more than 30), in accordance with American Society of Echocardiography guidance. In patients with two or more serial examinations, the sequence of positive and negative results over time is recorded and the longitudinal pattern of residual shunt is classified.
Statistical analysis: continuous variables are summarized as mean with standard deviation or median with interquartile range, and categorical variables as frequency and percentage. Cumulative event rates are estimated by the Kaplan-Meier method and compared with the log-rank test. Cox proportional hazards models are used to estimate hazard ratios with 95 percent confidence intervals. Predictors of residual shunt are examined by logistic regression. Analyses are performed with R version 4.0 or later, and a two-sided p value below 0.05 is considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with recurrent ischemic stroke or transient ischemic attack
Time frame: 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
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.
Number of participants with residual right-to-left shunt on agitated saline transthoracic echocardiography, by shunt grade
Time frame: 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
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.
8 secondary outcomes
Number of participants who die from any cause
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time to spontaneous resolution of residual shunt
Time frame: 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
Predictors of residual right-to-left shunt on agitated saline transthoracic echocardiography
Time frame: 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
Functional status measured with the modified Rankin Scale
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Background: PubMed 28902590Saver 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.
- Background: PubMed 28902580Sondergaard 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.
- Background: PubMed 28902593Mas 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.
- Background: PubMed 29544871Lee 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.
- Background: PubMed 32422058Deng 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.
- Background: PubMed 39122559Witte 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.
- Background: PubMed 40828307Ujka 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.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared.
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Patent Foramen Ovale, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Foramen Ovale and Cryptogenic Stroke, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jung-Sun Kim, Professor (+82-2-2228-8335, kjs1218@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with recurrent ischemic stroke or transient ischemic attack (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07724171, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.