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AzTrials

Critical Congenital Heart DiseaseCHDNCT05351125

Outcomes Of Interventional Catheterization In Infants Less Than 3 Months With Critical Congenital Heart Disease

An observational study of Critical Congenital Heart Disease, run by YHAlattar.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Congenital heart disease is the most common birth defect affecting mostly 1 in 100 births(1), critical congenital heart disease is when there is low systemic cardiac output which requires urgent surgery or catheter intervention in the first year of life(2), in low-income countries CCHD is associated with severe high… Read more about this study

Who is it for?
Ages 12 hours to 3 months
Conditions the study is for
Critical Congenital Heart Disease
What is being tested?
cardiac catheterization
Type of treatment
Surgery or procedure
How many people
40 participants
Where
No sites listed yet
Study dates
28 Jun 2022to 30 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 hours to 3 months
  • All sexes
  • No healthy volunteers
  • Child

Study population: All infants less than 3 months of age with critical congenital heart disease requiring urgent cardiac catheter intervention

Who may be able to join

  • All infants less than 3 months of age with critical congenital heart disease requiring urgent cardiac catheter intervention including
  • Critical valvular aortic stenosis requiring aortic valvuoplasty.
  • Pulmonary valvuloplasty for critical valvular pulmonary stenosis.
  • Pulmonary valvuloplasty in pulmonary atresia with intact IVS after exclusion of RV-dependent coronary circulation.
  • PDA stenting in duct dependent congenital cyanotic heart disease.
  • Atrial septostomy to enhance atrial mixing (in transposition of great arteries with restrictive or no inter-atrial communication).
  • Balloon angioplasty of native coarctation as a palliative measure to stabilize a patient with severely depressed ventricular function.

Who cannot join

  • <!-- -->
  • patent ductus arteriosus closure
  • percutaneous temporary pacemaker implantation for arrhythmia
  • diagnostic catheterization.
  • prematurity
  • low birth weight
  • bleeding diathesis
  • sepsis.

Trial locations and contacts

No sites are listed yet.

Yomna Hussein Mohammed Hussein Alattar H Alattar, assisstant lecturer contact

01008855990

alattaryomna@yahoo.com

Khaled A Sanousy, professor contact

0 100 306 8421

Khalidelsanousy@yahoo.com

About this study

Congenital heart disease is the most common birth defect affecting mostly 1 in 100 births(1), critical congenital heart disease is when there is low systemic cardiac output which requires urgent surgery or catheter intervention in the first year of life(2), in low-income countries CCHD is associated with severe high mortality rate due to low health resources, in high-income countries, CCHD is associated with life-long morbidities and a high burden on the health care systems(1-3)

Read the detailed description

CCHD are classified into three major components:

Left heart obstructions representing 30-40%, complete transposition of the great arteries (mostly 30%), and right heart obstructions (20-30%).

CCHD may present with signs of low cardiac output and hypoperfusion in case of duct dependent systemic circulation or central cyanosis not responding to oxygen in duct dependent pulmonary circulation or two parallel circulations.

Critical congenital heart disease is classified into :

  • Congenital heart disease with duct-dependent systemic blood flow (SBF) as:
  1. Critical aortic stenosis
  2. Critical coarctation of the aorta
  • Congenital heart disease with duct-dependent pulmonary blood flow (PBF) as:
  1. Critical pulmonary stenosis.
  2. Pulmonary atresia with intact septum.
  3. Severe types of Fallot's tetralogy and pulmonary atresia with VSD.
  • Complete transposition of the great arteries (d-TGA) Classified as non-mixture or inadequate shunting at atrial, ventricular, or duct level.

Recent advances in percutaneous neonatal cardiac interventions have improved survival, decreased morbidity, and mortality in newborns with CCHD compared with surgery(4).

Pediatric cardiac catheter interventions have been an established way for the management of CCHD(5).

Balloon atrial septestomy is the standard intervention for patients with D-TGA with ineffective mixing (6), BAS is indicated when there is time lag between diagnosis and arterial switch operation due to transportation and lack of competent surgical team, and it is also indicated in patients with d-TGA with restrictive inter-atrial communication(7).

Ductus arteriosus stenting is used to maintain a reliable source of pulmonary blood flow in patients with duct-dependent cyanotic CHD(5).

The main advantage of ductus arteriosus stenting is the avoidance of surgery and shunt-related side effects , also it promotes significant PA growth compared to a BT shunt alone (8).

Balloon aortic and pulmonary valvuloplasty and balloon coarctation angioplasty are now established procedures for the management of patients with critical pulmonary or aortic stenosis(9).

Being tested
cardiac catheterization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cardiac catheterizationProcedure or surgery

    catheterization in critical congenital heart disease requiring atrial septostomy or balloon valvuloplastyor PDA stenting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the effect of cardiac catheter interventions in infants < 3 months with critical congenital heart disease on morbidity and mortality

    the success rates of urgent cardiac cathetrization

    Type of procedure.

    Procedural outcome:

    Measured: 6 months post catheterization

  2. Delineation of failure of the procedure and its causes

    failure of cardiac catheterization with urgent referral to surgery

    Measured: immediate post procedure up to 1montn

Secondary outcomes (2)

  1. Complications of trans catheter intervention

    Complications

    1. major complications ( Life-threatening complications requiring urgent unplanned surgery or intervention) as cardiac tamponade, cardiac perforation, cardiac valve injury, allergy to anesthesia or drugs, and CPR maneuvers.
    2. (Procedure-related non-life-threatening complications) as: Vascular thrombosis at the site of access, arrhythmia, hypothermia, aggravation of hypoxia, renal insufficiency, and blood loss.

    Measured: 6 month

  2. the least and sufficient Procedure time , the radiation time and its side effects

    1. Procedure time including (anesthesia time, access time, catheter intervention time, and fluoroscopy time)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2022
  2. Study start28 Jun 2022 (estimated)
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05351125
Sponsor's protocol ID
catheterization in CHD
Acronym
CHD
Status last verified
Apr 2022
First submitted
28 Mar 2022
Last updated
28 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bakker MK, Bergman JEH, Krikov S, Amar E, Cocchi G, Cragan J, de Walle HEK, Gatt M, Groisman B, Liu S, Nembhard WN, Pierini A, Rissmann A, Chidambarathanu S, Sipek A Jr, Szabova E, Tagliabue G, Tucker D, Mastroiacovo P, Botto LD. Prenatal diagnosis and prevalence of critical congenital heart defects: an international retrospective cohort study. BMJ Open. 2019 Jul 2;9(7):e028139. doi: 10.1136/bmjopen-2018-028139.

    PubMed 31270117

  • Khalil M, Jux C, Rueblinger L, Behrje J, Esmaeili A, Schranz D. Acute therapy of newborns with critical congenital heart disease. Transl Pediatr. 2019 Apr;8(2):114-126. doi: 10.21037/tp.2019.04.06.

    PubMed 31161078

  • Arth AC, Tinker SC, Simeone RM, Ailes EC, Cragan JD, Grosse SD. Inpatient Hospitalization Costs Associated with Birth Defects Among Persons of All Ages - United States, 2013. MMWR Morb Mortal Wkly Rep. 2017 Jan 20;66(2):41-46. doi: 10.15585/mmwr.mm6602a1.

    PubMed 28103210

  • Melekoglu AN, Baspinar O. Transcatheter cardiac interventions in neonates with congenital heart disease: A single centre experience. J Int Med Res. 2019 Feb;47(2):615-625. doi: 10.1177/0300060518806111. Epub 2018 Oct 30.

    PubMed 30373426

  • Alakhfash AA, Jelly A, Almesned A, Alqwaiee A, Almutairi M, Salah S, Hasan M, Almuhaya M, Alnajjar A, Mofeed M, Nasser B. Cardiac Catheterisation Interventions in Neonates and Infants Less Than Three Months. J Saudi Heart Assoc. 2020 May 12;32(2):149-156. doi: 10.37616/2212-5043.1051. eCollection 2020.

    PubMed 33154909

  • Kumar N, Shaikh AS, Kumari V, Patel N. Echocardiography guided bed side balloon atrial septostomy in dextro transposed great arteries (dTGA) with intact ventricular septum (IVS): A resource limited country experience. Pak J Med Sci. 2018 Nov-Dec;34(6):1347-1352. doi: 10.12669/pjms.346.15792.

    PubMed 30559783

Questions about this trial

What is this clinical trial studying?

An observational study of Critical Congenital Heart Disease, run by YHAlattar.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yomna Hussein Mohammed Hussein Alattar H Alattar, assisstant lecturer (01008855990, alattaryomna@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the effect of cardiac catheter interventions in infants < 3 months with critical congenital heart disease on morbidity and mortality (time frame: 6 months post catheterization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05351125, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.

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