Investigating cerebral microembolization in patients with PFO closure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: chaowuyan@163.com
• Phone: 13811967138

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pulmonary embolism with right-to-left heart or lung shunts

  This project will see if people with an acute pulmonary embolism who also have a right-to-left shunt (like a PFO or ASD) are more likely to have a stroke than PE patients without a shunt.

  Recruiting Tufts Medical Center · Boston, Massachusetts · NCT07519876

• PFO closure versus blood thinners to prevent repeat stroke in older adults

  This study will test whether closing a patent foramen ovale or taking direct oral anticoagulants better prevents repeat strokes in adults over 60 with PFO-related embolic stroke.

  Recruiting at 3 sites Taichung Veterans General Hospital · Taichung and 2 other locations · NCT07479147

• Non-invasive detection of right-to-left heart shunts

  This project will test if a new handheld, battery-powered ultrasound device can detect right-to-left heart shunts in patients having a TEE with a bubble study for suspected PFO.

  Recruiting Scripps Health · La Jolla, California · NCT07420400

• Follow-up on the Lifetech Cera™ ASD Occluder for heart defect treatment

  This study is looking to see how well the Lifetech Cera™ ASD Occluder works and if it’s safe for people who have had it implanted to fix a heart defect.

  Recruiting Lifetech Scientific (Shenzhen) Co., Ltd. · Myszków and 5 other locations · NCT06849635

• Using 3D Echocardiography to Improve Device Closure for Atrial Septal Defect

  This study tests if using 3D heart imaging can help doctors choose the right size device to close holes in the heart for people with atrial septal defects.

  Recruiting Asan Medical Center · Seoul · NCT02097758

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.