Outcomes Of Interventional Catheterization In Infants Less Than 3 Months With Critical Congenital… (NCT05351125) | Clinical Trial Compass
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Outcomes Of Interventional Catheterization In Infants Less Than 3 Months With Critical Congenital Heart Disease
40 participantsStarted 2022-06-28
Plain-language 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)
Who can participate
Age range
12 Hours – 3 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. Pulmonary valvuloplasty for critical valvular pulmonary stenosis.
Exclusion criteria
. 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.
. patent ductus arteriosus closure
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the effect of cardiac catheter interventions in infants < 3 months with critical congenital heart disease on morbidity and mortality
Timeframe: 6 months post catheterization
2
Delineation of failure of the procedure and its causes
Timeframe: immediate post procedure up to 1montn
Trial details
NCT IDNCT05351125
SponsorYHAlattar
Sponsor typeOTHER
Study typeOBSERVATIONAL
Primary completion2023-12-30
Contact for this trial
Yomna Hussein Mohammed Hussein Alattar H Alattar, assisstant lecturer