Investigating cerebral microembolization in patients with PFO closure

De Novo Cerebral Microembolization Associated With Patent Foramen Ovale Closure

This study is trying to see if patients with a heart condition called PFO who undergo a closure procedure experience tiny blood clots in the brain and how these might relate to existing clots in the heart.

Quick facts

• Study type: Observational
• Enrollment: 800 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (Government)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06347276 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the occurrence of de novo cerebral microembolization in patients undergoing transcatheter closure of patent foramen ovale (PFO) or atrial septal defect (ASD). It will also evaluate the relationship between these microemboli and the presence of thrombus within the PFO. The study focuses on patients with a history of embolic stroke or migraines, as well as asymptomatic individuals with high-risk anatomical features. By utilizing advanced imaging techniques, the study seeks to provide insights into the potential risks associated with PFO closure procedures.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 65 with documented PFO and a history of embolic stroke or migraines.

Not a fit: Patients with known vascular risk factors such as hypertension or diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of the risks associated with PFO closure and improve patient outcomes by informing better clinical practices.

How similar studies have performed: While similar studies have explored PFO and its associated risks, this specific investigation into cerebral microembolization post-closure is relatively novel.

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 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.

Where this trial is running

Beijing, Beijing Municipality

• Chaowu Yan — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Chaowu Yan, PhD MD — Cardiovascular Institute and Fuwai Hospital
• Study coordinator: Chaowu Yan, PhD MD

Conditions Thrombosis Cardiac; Atrial Septal Defect; Patent Foramen Ovale; Patent foramen ovale; stroke; migraine; thrombus