๐ฌIn plain words
What the trial is, and whether it could suit you
Aortic valve disease counts up to 5% of cases of congenital heart disease being one of the most common congenital malformations of the cardiovascular system. This disease requires replacement of the damaged valve which in itself is not a trivial task to complete in children as there is still no available best practice for valve replacement. Today, the following alternative variants are performed in children: mechanical aortic prosthesis, xenografts, allografts, and pulmonary autograft (Ross procedure) and each has its potential advantages and disadvantages.
Mechanical aortic prostheses require lifelong anticoagulation therapy and repeated surgeries to replace mechanical valves during child growth. Available xenografts in children also has suboptimal results not only because of absence of growth potential, but also due to development of degenerative changes in biological tissue of the gr
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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:
โข Refusal of patient's caregivers to participate further in the study.
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What it tests
- Physical examination
- The Ross Classification for Heart Failure in Children
- The Aristotle score
- Assessment of administered specific therapy
- Multispiral computed tomography/3D echocardiography
National Medical Research Center of Children's Health
Moscow, Russia
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.