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Cerebral Microembolization Associated With PFO Closure

De Novo Cerebral Microembolization Associated With Patent Foramen Ovale Closure

NCT06347276•China National Center for Cardiovascular Diseases

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•PFO group
•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).
•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) 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
•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.

Locations (1)

Chaowu Yan

Beijing, Beijing Municipality, China

Key Dates

Start Date

January 1, 2024

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2026

Last Updated

July 24, 2025

Enrollment

800

ESTIMATED participants

Conditions

Thrombosis CardiacAtrial Septal DefectPatent Foramen Ovale (PFO)

Interventions

PFO occluder; ASD occluder

DEVICE

Contacts

Chaowu Yan, PhD MD

CONTACT

13811967138 chaowuyan@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Cerebral Microembolization Associated With PFO Closure

Inclusion Criteria

Exclusion Criteria

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