NCT06347276

Cerebral Microembolization Associated With PFO Closure

De Novo Cerebral Microembolization Associated With Patent Foramen Ovale Closure

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	PFO occluder; ASD occluder	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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-04-04
• Last updated: 2025-07-24

Locations

1 site across 1 country: China