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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Other
Study Type: Observational
SUMMARY

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 graft leaflets. Allograft tissues are exposed to rapid biodegradation in the recipient body and thus requiring repeated surgeries associated with higher difficulty, high risk of hemorrhages, and injury of the coronary injuries. Ross procedure was proposed as theoretically the most evidence-based reconstruction of the aortic valve in children. Even successfully performed Ross operation transforms one-valve disorder into two-valve disease. The accumulation of knowledge on the anatomy of the aortic root and improvement of surgical techniques led to the development of new methods for reconstruction of the valve function. The technique is widely applied in adult cardiac surgery, uses glutaraldehyde-treated autopericardium for augmentation of the leaflets. Absence of foreign material provides no need for anticoagulation therapy. Potentially, reconstruction of the aortic valve with autopericardium can be widely used in children. Aim is to study safety, clinical and hemodynamic efficacy of the method of the aortic valve reconstruction with autopericardium in children with aortic valve disease. Patients aged 29 days to 12 years will be included into the study. The data according to the protocol of the study will be assessed at the stage of inclusion, during the surgery, in 30 days after the surgery, and in 1, 2, and 3 years after the surgery. Data about all the patients included into the research will be analyzed in order to study the endpoints and achieve the research aim.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 29 days
Maximum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
National Medical Research Center of Children's Health
RECRUITING
Moscow
Contact Information
Primary
Vladimir P. Miroshnichenko, PhD
miroshnichenko@nczd.ru
+7 499 134-04-70
Backup
Alexander A. Lezhnev, PhD
lezhnev.aa@nczd.ru
+7 495 967-14-20
Time Frame
Start Date: 2020-02-18
Estimated Completion Date: 2027-10
Participants
Target number of participants: 40
Treatments
Cohort 1
We will study safety, clinical and hemodynamic efficacy of the method of the aortic valve reconstruction with autopericardium in children with aortic valve disease.
Related Therapeutic Areas
Sponsors
Leads: National Medical Research Center for Children's Health, Russian Federation

This content was sourced from clinicaltrials.gov