NCT06347276|Recruiting
Cerebral Microembolization Associated With PFO Closure
De Novo Cerebral Microembolization Associated With Patent Foramen Ovale Closure
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De Novo Cerebral Microembolization Associated With Patent Foramen Ovale Closure
Sponsor study identifier
observational
800
1 country
1
Study Start
January 1, 2024
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study aims to investigate (1) the de novo cerebral microembolization in patients who undergo transcatheter closure of PFO or ASD, and (2) evaluate the relationship between de novo cerebral microembolization and in situ thrombus within PFO.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2024
Actual (reported)March 29, 2024
Actual (reported)April 4, 2024
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
De novo cerebral microembolization
cerebral microembolization with diffusion-weighted magnetic resonance imaging
24 hours to 4 weeks after closure of PFO/ASD
Before PFO closure, all patients will undergo brain DW-MRI. During PFO closure, all patients will undergo right atrial angiography to opacify the PFO, and OCT is used to evaluate the PFO microstructure during angiography while the patient performs the Valsalva maneuver. The presence or absence of in situ thrombus within the PFO will be determined, and thrombus size will be measured. Postoperatively, DW-MRI will be performed 24 hours and one month after the transcatheter closure procedure.
Before ASD closure, all patients will undergo brain DW-MRI. After the transcatheter closure of ASD, DW-MRI will be performed 24 hours and one month postoperatively.
Transcatheter closure of atrial septal defect (ASD) and patent foramen ovale (PFO) All cases will be examined with DW-MRI preoperatively, and DW-MRI will be repeated 24 hours and 4 weeks after the transcatheter closure procedure.
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In this study, there are two groups of the patients who will undergo transcatheter closure. (1) PFO patients (n=600); (2) ASD patients (n=200). Before transcatheter closure, all patients will undergo brain DW-MRI. After the transcatheter closure, DW-MRI will be performed 24 hours and 4 weeks postoperatively. In addition, the presence or absence of in situ thrombus within the PFO will be determined in patients with PFO.
Chaowu Yan
Beijing, Beijing Municipality, 100037, China
Yan C, Li H, Wang C, Yu H, Guo T, Wan L, Yundan P, Wang L, Fang W. Frequency and Size of In Situ Thrombus Within Patent Foramen Ovale. Stroke. 2023 May;54(5):1205-1213. doi: 10.1161/STROKEAHA.122.041524. Epub 2023 Mar 9.
Yan C, Li H. Preliminary Investigation of In situ Thrombus Within Patent Foramen Ovale in Patients With and Without Stroke. JAMA. 2021 May 25;325(20):2116-2118. doi: 10.1001/jama.2021.4359.
Chaowu Yan, PhD MD
Cardiovascular Institute and Fuwai Hospital
First Submitted
March 29, 2024
First Posted
April 4, 2024
Study Start
January 1, 2024
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Internal Microstructure of Patent Foramen Ovale Related to Stroke
Contact the study team to confirm eligibility.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 24, 2025
Record last verified: 2025-07
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Source: ClinicalTrials.gov.
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