Results of the Aortic Valve Reconstruction in Children

RecruitingOBSERVATIONAL
Enrollment

40

Participants

Timeline

Start Date

February 18, 2020

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2027

Conditions
Aortic Valve Insufficiency
Interventions
DIAGNOSTIC_TEST

Physical examination

A physical examination is a routine screening procedure used to investigate a patient's symptoms or complaints. It consists of a series of questions regarding patient medical history followed by an examination of the symptoms to determine the correct diagnosis and treatment plan.

DIAGNOSTIC_TEST

The Ross Classification for Heart Failure in Children

The assessment is performed by pediatric cardiologist according to the classic Ross scale. One of the 4 classes of chronic heart failure is registered.

DIAGNOSTIC_TEST

The Aristotle score

Surgical risks will be assessed by the ARISTOTLE score developed specially for the task. The calculation will be performed online, available from http://www.aristotleinstitute.org.

OTHER

Assessment of administered specific therapy

"The data will be registered as groups of administered medicines:~* Antiplatelet agents~* Loop diuretics~* Potassium-sparing diuretics~* Angiotensin-converting enzyme inhibitors"

DIAGNOSTIC_TEST

Multispiral computed tomography/3D echocardiography

"All patients enrolled in the study should be routinely examined with multispiral computed tomography (MS-CT) or 3D-echo before surgery and 3 years later. As a result, a 3D aortic root reconstruction will be made to assess its size and anatomy and subsequently build a 3D soft model for surgery imitation.~At the study onset, we plan to perform MS-CT, then 3D-echo. If the correlation resulting from 3D-echo and the actual sizes will be high, the isolated 3D-echo will be preferred in the future.~If none of the methods is available, the patients will not be enrolled in the study.~The following data will be registered for further analysis:~* Perimeter of the aortic valve~* Diameter of the aortic valve at sinuses level~* Height of the aortic sinuses~* Morphology of the aortic valve"

DIAGNOSTIC_TEST

Transthoracic and transesophageal echocardiography

"Transthoracic echocardiography is carried out at baseline, at discharge and then annually. It is performed in order to assess the contractile function of the heart and hemodynamic characteristics of the aortic valve and its autopericardium graft.~Transesophageal echocardiography is carried out directly after the withdrawal of the artificial circulation when performing augmentation of the aortic valve with autopericardium in order to asses hemodynamic characteristics of the aortic neo-valve."

DIAGNOSTIC_TEST

12-lead electrocardiogram

"Registering 12-lead electrocardiogram (ECG) is used as a tool for assessment of the regularity of the heart rhythm as well as screening and predictive tool for assessment of fibrosis and hypertrophy processes in the myocardium. The following data will be registered:~* Heart rate~* Sinus rhythm (yes/no)~* Positive R wave in leads V5-6~* Angle α less than 0~* Presence/absence of abnormal Q wave~* Presence/absence of ST-segment depression in precordial leads"

Trial Locations (1)

119296

RECRUITING

National Medical Research Center of Children's Health, Moscow

All Listed Sponsors
lead

National Medical Research Center for Children's Health, Russian Federation

OTHER_GOV