Results of the Aortic Valve Reconstruction in Children

Launched by NATIONAL MEDICAL RESEARCH CENTER FOR CHILDREN'S HEALTH, RUSSIAN FEDERATION · Nov 11, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new method for repairing the aortic valve in children who have aortic valve insufficiency, a condition where the valve doesn't close properly, allowing blood to flow backward. Traditional treatments often involve replacing the damaged valve with various types of prosthetics, which can require long-term medication and multiple surgeries as the child grows. This new technique uses a special material from the child's own heart lining, which may avoid the need for ongoing medication and reduce the number of surgeries needed.

To participate in this study, children aged between 29 days and 12 years with specific heart conditions related to aortic valve insufficiency may be eligible. Caregivers will need to give informed consent after understanding the study's purpose and procedures. Participants will have their health monitored before surgery and at several points afterward, including 30 days, 1 year, 2 years, and 3 years post-surgery, to evaluate how well the new repair method works. Overall, this trial aims to improve treatment options for young patients with aortic valve issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age from 29 days to 12 years
• • Patient's official caregivers have to sign the informed consent after they are thoroughly explained the meaning of the study, its protocol and timelines.
• • Patients with manifestations, with mean gradient at the aortic valve \>40 mmHg with normal left ventricular ejection fraction (LVEF), or patients with manifestations with the mean gradient \< 40 mmHg with decreased LVEF, or patients with manifestations with severe aortic insufficiency, or patients without manifestations, but with decreased LVEF with aortic insufficiency, or patients with concomitant moderate aortic insufficiency and moderate aortic stenosis with manifestations.
• • Aortic Z-score over -1,5
• • Absence of subvalvular and supravalvular aortic stenosis
• • Absence of intracardiac malformations requiring correction, except for septal defects
• Non-inclusion criteria:
• • Known hypersensitivity to aspirin, heparin, nitinol, intravenous contrast or contradictions to their administration due to other causes.
• • Previous replacement of the aortic valve with mechanical or xenografts.
• • Confirmed active sepsis or endocarditis.
• • Hypoplasia of the fibrous ring of the aortic valve with Z score under -1,5.
• • Life expectancy less than 3 years due to concomitant diseases.
• • Participation in another clinical research.
• • Indications for urgent surgery.
• • Intracardiac malformations requiring momentary surgical correction.
• • Geographical instability of a patient and his/her official caregivers, complicating significantly the constant contact during the study
• Exclusion Criteria:
• • • Refusal of patient's caregivers to participate further in the study.