Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects

Launched by FIRST AFFILIATED HOSPITAL OF GUANGXI MEDICAL UNIVERSITY · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new, dissolvable device designed to close a specific type of hole in the heart called an outlet ventricular septal defect (outlet VSD). This hole is present from birth and affects the wall between the heart’s lower chambers. The main goal of the study is to see if this device is safe and works well, especially looking at how it might affect the nearby aortic valve, which helps control blood flow from the heart to the body.

The trial is open to children and adults who are at least 1 year old and weigh 10 kilograms (about 22 pounds) or more. To join, participants must have an outlet VSD of a certain size, with no serious valve problems or other heart conditions needing surgery. People with severe lung blood pressure issues, blood clots in the heart, pregnancy, or recent infections won’t be eligible. If someone joins, they will receive the bioabsorbable device through a minimally invasive procedure (using a catheter) to close the heart defect, and the researchers will carefully monitor heart function, especially the aortic valve, to ensure safety and effectiveness. This study is not yet recruiting but aims to offer a new treatment option that avoids permanent implants in the heart.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥1 year and weight ≥10 kg
• • Outlet VSD without ventricular malalignment
• • Maximal defect diameter ≤12mm with subaortic rim ≤1mm and no ≥mild aortic regurgitation by by transthoracic or transesophageal echocardiography
• • Written informed consent
• Exclusion Criteria:
• • Outlet VSD with a fibrous postero-inferior rim
• • Concurrent cardiac conditions requiring surgical correction
• • Severe pulmonary hypertension (PVR \> 5 WU, assessed by right heart catheterization )
• • Intracardiac thrombus
• • Pregnancy
• • Active systemic infection within 1 month