Bioabsorbable plug for outlet heart hole: safety study
Part of Genetic & congenital, Heart & circulation clinical trials.
This trial tests a new bioabsorbable (naturally dissolving) device to close a specific type of hole in the heart (outlet VSD) without surgery. It focuses on safety and how the device affects the aortic valve.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You or your child must be at least 1 year old and weigh at least 10 kg (22 lb).
- The hole in the heart is in the upper part of the wall between the lower chambers (called outlet VSD) and the heart is otherwise normally formed.
- The hole is 12 mm or smaller, with a very short edge (less than 1 mm) near the aortic valve, and the aortic valve is not leaking more than mildly.
- No other heart problems needing surgery, no severe lung artery pressure, no blood clot in the heart, and no active infection or pregnancy.
- You and your doctor agree to the trial by signing a consent form.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
Similar studies
Other trials that look related to this one.
This trial monitors children who had a ventricular septal defect (VSD) closed with a device to see how they do over time. It checks if the closure stays effective and if there are any long-term issues.
This follow-up study monitors how well and how safely the Occlutech mVSD device works to close certain muscular heart “holes” (ventricular septal defects). You may join if you already had the device placed and can return for scheduled checkups to help doctors learn long-term outcomes.
This study gathers information on a procedure to close a specific type of heart hole using a device inserted through a catheter. It aims to evaluate how well this procedure works in different medical centers.
This study checks how well and how safely the Occlutech PDA Occluder works over time to close a patent ductus arteriosus (PDA). You may be considered if your PDA can be treated with this non-surgical device and you can return for follow-up visits.
This trial tests a new, dissolvable device to close a hole in the heart called a PFO. It may help people who have had a stroke or mini-stroke linked to this hole.
This trial looks at whether a special 3D ultrasound picture helps doctors safely place a small device to close an atrial septal defect (ASD), a hole in the heart’s upper chambers. If you need ASD closure and are suitable for a device, the results could help improve guidance and outcomes.
Hear when a new Congenital Heart Defects trial opens
We’ll email you when one opens — at most once a week, no account needed, unsubscribe anytime.