Cerebral Microembolization Associated With PFO Closure

NCT06347276 | Recruiting

• 1 other identifier: 2023-RW320-08
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thrombosis Cardiac; Atrial Septal Defect; Patent Foramen Ovale (PFO)

Keywords

Patent foramen ovale; stroke; migraine; thrombus

Outcome Measures

Primary Outcomes (1)

• De novo cerebral microembolization

  cerebral microembolization with diffusion-weighted magnetic resonance imaging

  24 hours to 4 weeks after closure of PFO/ASD

Study Arms (2)

PFO closure

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.

Device: PFO occluder; ASD occluder

ASD closure

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.

Device: PFO occluder; ASD occluder

Interventions

PFO occluder; ASD occluder DEVICE

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.

ASD closure; PFO closure

Eligibility Criteria

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

Study Population

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.

You may qualify if:

• \) age 18 to 65 years; 2) documented PFO with medium-to-large shunts (≥ 20 microbubbles by c-TCD at rest or during the Valsalva maneuver); 3) history of embolic stroke (based on brain magnetic resonance imaging within 24 hours after symptom onset) or TIA within 6 months without other identifiable causes; 4) history of migraine for more than one year without other identifiable causes; 5) asymptomatic group: incidental finding of PFO in asymptomatic individuals, and presence of high-risk activities and/or anatomical features related to PFO (high-risk activities were defined as those in which the Valsalva maneuver was performed frequently or those that increased the risk of venous gas formation; and high-risk anatomical features included atrial septal aneurysm and/or curtain pattern on c-TCD).

You may not qualify if:

• \) presence of any known vascular risk factor, including hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking and obesity; 2) history of embolic stroke or TIA within the past one month; 3) history of deep vein thrombosis or pulmonary embolism; 4) presence of coronary artery disease and carotid artery lesions; 5) presence of coexistent cardiovascular structural malformations or diseases; 6) allergy to contrast medium; 7) refusal to participate.
• ASD group
• \) age 18 to 65 years; 2) secundum ASD size 10 to 20 mm, with sufficient surrounding rims, except the aortic rim; 3) right heart catheterization: resting SPAP \< 50 mm Hg, Qp/Qs ≥ 1.5 and PVR \< 5 WU.
• \) presence of any known vascular risk factor, including hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking and obesity; 2) associated with other cardiac abnormalities or diseases; 3) resting SPAP ≥50 mm Hg and resting PVR ≥5 Wood units;4) primum or sinus venosus type ASD; 5) presence of intracardiac thrombi, permanent contraindications to platelet therapy, and allergic reaction to nickel.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Beijing Anzhen Hospital: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator
• Tibet Autonomous Region People's Hospital: collaborator
• Beijing Tiantan Hospital: collaborator
• Xuanwu Hospital, Beijing: collaborator

Study Sites (1)

Chaowu Yan

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 36891906 BACKGROUND

• 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.

  PMID: 34032839 BACKGROUND

MeSH Terms

Conditions

Heart Septal Defects, Atrial; Foramen Ovale, Patent; Stroke; Migraine Disorders; Thrombosis

Condition Hierarchy (Ancestors)

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; Headache Disorders, Primary; Headache Disorders; Embolism and Thrombosis

Study Officials

• Chaowu Yan, PhD MD

  Cardiovascular Institute and Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chaowu Yan, PhD MD

CONTACT

13811967138; chaowuyan@163.com

Study Design

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

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

CN (1)