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Recruiting NCT06347276

Cerebral Microembolization Associated With PFO Closure

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Trial Parameters

Condition Thrombosis Cardiac
Sponsor China National Center for Cardiovascular Diseases
Study Type OBSERVATIONAL
Phase N/A
Enrollment 800
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2024-01-01
Completion 2026-12-31
Interventions
PFO occluder; ASD occluder

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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.

Eligibility Criteria

PFO group 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 o

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