Actively Recruiting
Cerebral Microembolization Associated With PFO Closure
Led by China National Center for Cardiovascular Diseases · Updated on 2025-07-24
800
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
C
China National Center for Cardiovascular Diseases
Lead Sponsor
B
Beijing Anzhen Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Cerebral Microembolization Associated With PFO Closure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years
- Documented patent foramen ovale (PFO) with medium-to-large shunts (≥ 20 microbubbles by c-TCD)
- History of embolic stroke or transient ischemic attack (TIA) within 6 months without other causes
- History of migraine for more than one year without other causes
- Incidental PFO finding with high-risk activities and/or anatomical features related to PFO
- For atrial septal defect (ASD): age 18 to 65 years
- Secundum ASD size 10 to 20 mm with sufficient surrounding rims except the aortic rim
- Right heart catheterization showing resting SPAP < 50 mm Hg, Qp/Qs ≥ 1.5, and PVR < 5 Wood units
You will not qualify if you...
- Presence of any known vascular risk factors including hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking, or obesity
- History of embolic stroke or TIA within the past one month
- History of deep vein thrombosis or pulmonary embolism
- Presence of coronary artery disease and carotid artery lesions
- Coexistent cardiovascular structural malformations or diseases
- Allergy to contrast medium
- Refusal to participate
- For ASD group: associated other cardiac abnormalities or diseases
- Resting SPAP ≥ 50 mm Hg and resting PVR ≥ 5 Wood units
- Primum or sinus venosus type ASD
- Presence of intracardiac thrombi, permanent contraindications to platelet therapy, or allergic reaction to nickel
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chaowu Yan
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
Research Team
C
Chaowu Yan, PhD MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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