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

Critical Congenital Heart Disease Clinical Trial

— CHD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05351125
• Other study ID #: catheterization in CHD
• Status: Not yet recruiting
• Start date: June 28, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2022
• Source: Assiut University
• Contact: Yomna Hussein Mohammed Hussein Alattar H Alattar, assisstant lec
• Phone: 01008855990
• Email: alattaryomna[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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)

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

Inclusion Criteria:

• All infants less than 3 months of age with critical congenital heart disease requiring urgent cardiac catheter intervention including

1. Critical valvular aortic stenosis requiring aortic valvuoplasty.

2. Pulmonary valvuloplasty for critical valvular pulmonary stenosis.

3. Pulmonary valvuloplasty in pulmonary atresia with intact IVS after exclusion of RV-dependent coronary circulation.

4. PDA stenting in duct dependent congenital cyanotic heart disease.

5. Atrial septostomy to enhance atrial mixing (in transposition of great arteries with restrictive or no inter-atrial communication).

6. Balloon angioplasty of native coarctation as a palliative measure to stabilize a patient with severely depressed ventricular function.

Exclusion Criteria:

1. patent ductus arteriosus closure

2. percutaneous temporary pacemaker implantation for arrhythmia

3. diagnostic catheterization.

4. prematurity

5. low birth weight

6. bleeding diathesis

7. sepsis.

Related Conditions & MeSH terms

• Critical Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Procedure:
• cardiac catheterization
catheterization in critical congenital heart disease requiring atrial septostomy or balloon valvuloplastyor PDA stenting

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
YHAlattar

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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:	6 months post catheterization
Primary	Delineation of failure of the procedure and its causes	failure of cardiac catheterization with urgent referral to surgery	immediate post procedure up to 1montn
Secondary	Complications of trans catheter intervention	Complications; 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.; (Procedure-related non-life-threatening complications) as: Vascular thrombosis at the site of access, arrhythmia, hypothermia, aggravation of hypoxia, renal insufficiency, and blood loss.	6 month
Secondary	the least and sufficient Procedure time , the radiation time and its side effects	3. Procedure time including (anesthesia time, access time, catheter intervention time, and fluoroscopy time)	6 months