RecruitingNCT04162444

Results of the Aortic Valve Reconstruction in Children

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

Sponsor

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

Enrollment

40 participants

Start Date

Feb 18, 2020

Study Type

OBSERVATIONAL

Conditions

Aortic Valve Insufficiency

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

Min Age: 29 DaysMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is examining the long-term results of aortic valve reconstruction surgery in children with aortic valve disease. The aortic valve controls blood flow from the heart to the rest of the body, and when it is narrowed (stenosis) or leaking (insufficiency), it puts significant strain on the heart. In children, the challenge is to repair the valve in a way that will grow with the child and last many years, avoiding the need for valve replacement with a mechanical device that requires lifelong blood thinners. This study will follow children who have undergone reconstruction using their own pericardial tissue (tissue from around the heart) to build new valve leaflets. Researchers will track heart function, valve performance, and clinical outcomes over several years. You may be eligible if: - Your child is between 29 days and 12 years old - Your child has significant aortic valve disease meeting specific criteria (e.g., high pressure gradient, reduced heart function, or significant valve leakage) - Your child's aortic valve has an appropriate size (Z-score above -1.5) - Caregivers have provided informed consent You may NOT be eligible if: - Your child has had a previous aortic valve replacement - Your child has active infection or endocarditis - Your child has known allergy to aspirin, heparin, or contrast dye - Your child has other heart defects requiring urgent surgery at the same time - Life expectancy is less than 3 years due to other illnesses Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTPhysical 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_TESTThe 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_TESTThe 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.

OTHERAssessment 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_TESTMultispiral 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_TESTTransthoracic 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_TEST12-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