Results of the Aortic Valve Reconstruction in Children

NCT04162444 | Recruiting

• 1 other identifier: 16072019
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Valve Insufficiency

Keywords

Aortic Valve Insufficiency/surgery; Aortic Valve/surgery; Child; Reconstructive Surgical Procedures/methods; Cardiac Surgical Procedures; Hemodynamics; Pericardium/transplantation; Transplantation, Autologous; Treatment Outcome; Heart Valve Prosthesis Implantation

Outcome Measures

Primary Outcomes (1)

• Death Rate

  Patient's death due to various causes during the first 30 days after the surgery.

  From baseline till 1 month after the surgery

Secondary Outcomes (9)

• Number of Participants with Repeat Aortic Valve Surgery

  During the 5-6 years of the follow-up period since the surgery

• Number of Participants with Aortic Valve Mean Gradient over 40 mmHg

  During the 5-6 years of the follow-up period since the surgery

• Number of Participants with Aortic Insufficiency Stage 2-4

  During the 5-6 years of the follow-up period since the surgery

• Neo-aortic valve effective area less than 1.0 cm2/m2

  During the 5-6 years of the follow-up period since the surgery

• Number of Participants with Hemorrhage requiring surgery

  During the 5-6 years of the follow-up period since the surgery

Study Arms (1)

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.

Diagnostic Test: Physical examination; Diagnostic Test: The Ross Classification for Heart Failure in Children; Diagnostic Test: The Aristotle score; Other: Assessment of administered specific therapy; Diagnostic Test: Multispiral computed tomography/3D echocardiography; Diagnostic Test: Transthoracic and transesophageal echocardiography; Diagnostic Test: 12-lead electrocardiogram

Interventions

Physical examination DIAGNOSTIC_TEST

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.

Also known as: Medical examination, Clinical examination

Cohort 1

The Ross Classification for Heart Failure in Children DIAGNOSTIC_TEST

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

Also known as: Assessment of heart failure according to Ross scale

Cohort 1

The Aristotle score DIAGNOSTIC_TEST

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.

Also known as: Assessment of surgical risks according to the ARISTOTLE score

Cohort 1

Assessment of administered specific therapy OTHER

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

Cohort 1

Multispiral computed tomography/3D echocardiography DIAGNOSTIC_TEST

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

Also known as: MS-CT/3D-echo

Cohort 1

Transthoracic and transesophageal echocardiography DIAGNOSTIC_TEST

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.

Cohort 1

12-lead electrocardiogram DIAGNOSTIC_TEST

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

Also known as: 12-lead ECG

Cohort 1

Eligibility Criteria

• Age: 29 Days - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The study will enroll the participants from the patients of the the Department of Cardiac Surgery with dysfunction of the native aortic valve with and without manifestations, with indications for the aortic valve reconstruction, and without concomitant supravalvular and subvalvular aortic stenosis and major congenital heart diseases.

You may qualify if:

• 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
• 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

You may not qualify if:

• Refusal of patient's caregivers to participate further in the study.

Sponsors & Collaborators

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

Study Sites (1)

National Medical Research Center of Children's Health

Moscow, 119296, Russia

RECRUITING

Related Publications (36)

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Related Links

• Dhand NK, Khatkar MS. (2014). Statulator: an online statistical calculator. Sample Size Calculator for Estimating a Single Proportion. Accessed 15 March 2019

MeSH Terms

Conditions

Aortic Valve Insufficiency

Interventions

Physical Examination; Echocardiography, Transesophageal; Electrocardiography

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Electrodiagnosis

Study Officials

• Dmitry V. Ryabtsev, PhD

  National Research Center of Children's Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vladimir P. Miroshnichenko, PhD

CONTACT

+7 499 134-04-70; miroshnichenko@nczd.ru

Alexander A. Lezhnev, PhD

CONTACT

+7 495 967-14-20; lezhnev.aa@nczd.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 14, 2019
• Study Start: February 18, 2020
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: IPD will be shared upon a request.

Locations

RU (1)