Cerebral Microembolization Associated With PFO Closure

Recruiting

• Conditions: Thrombosis Cardiac; Patent Foramen Ovale (PFO); Atrial Septal Defect
• Interventions: Device: PFO occluder; ASD occluder

• Registration Number: NCT06347276
• Lead Sponsor: China National Center for Cardiovascular Diseases

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.

Detailed Description

Patent foramen ovale (PFO) is prevalent in the general population and it is commonly accepted that PFO is associated with various pathological conditions, including ischemic stroke, transient ischemic attack, migraines, and systemic or coronary embolization. In situ thrombus formation may play a role in patients with PFO-associated stroke or migraines. After transcatheter closure of PFO, peri-interventional cerebral embolic lesions have been detected. 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.

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-03-29
• Study First Submitted QC: 2024-03-29
• Study First Posted: 2024-04-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-06-11
• Last Update Posted: 2025-06-13
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. 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).

Exclusion Criteria

1. 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

Inclusion Criteria:

1. 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.

Exclusion Criteria:

1. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PFO closure	PFO occluder; ASD occluder	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.
ASD closure	PFO occluder; ASD occluder	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.

Primary Outcome Measures

Name	Time	Method
De novo cerebral microembolization	24 hours to 4 weeks after closure of PFO/ASD	cerebral microembolization with diffusion-weighted magnetic resonance imaging

Trial Locations

Locations (1)

Chaowu Yan; 🇨🇳 Beijing, Beijing, China