Aortic valve reconstruction in children with heart disease

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: miroshnichenko@nczd.ru
• Phone: +7 499 134-04-70

Similar studies

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

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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.