Aortic valve reconstruction in children with heart disease

Short-term and Midterm Results of the Aortic Valve Reconstruction With Autopericardium in Children

This study looks at different surgical options for fixing aortic valve problems in children with heart disease to see which methods work best and have the fewest complications.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 29 Days to 12 Years
• Sex: All
• Sponsor: National Medical Research Center for Children's Health, Russian Federation (other gov)
• Locations: 1 site (Moscow)
• Trial ID: NCT04162444 on ClinicalTrials.gov

What this trial studies

This observational study focuses on children with aortic valve insufficiency, a common congenital heart condition. It evaluates various surgical options for aortic valve reconstruction, including mechanical prostheses, xenografts, allografts, and the Ross procedure. The study aims to assess the outcomes and complications associated with these surgical interventions, utilizing physical examinations and advanced imaging techniques. By analyzing the effectiveness of these methods, the study seeks to identify the best practices for managing aortic valve disease in pediatric patients.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 29 days to 12 years with significant aortic valve insufficiency and specific echocardiographic findings.

Not a fit: Patients with known hypersensitivity to key medications or those with certain cardiac malformations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical techniques and outcomes for children with aortic valve insufficiency.

How similar studies have performed: While there have been various approaches to aortic valve reconstruction, this study's specific focus on pediatric patients and comparative analysis of techniques is relatively novel.

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.

Where this trial is running

Moscow

• National Medical Research Center of Children's Health — Moscow, Russia (RECRUITING)

Study contacts

• Principal investigator: Dmitry V. Ryabtsev, PhD — National Research Center of Children's Health
• Study coordinator: Vladimir P. Miroshnichenko, PhD

Conditions: Aortic Valve Insufficiency, Aortic Valve Insufficiency/surgery, Aortic Valve/surgery, Child, Reconstructive Surgical Procedures/methods, Cardiac Surgical Procedures, Hemodynamics, Pericardium/transplantation