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Clinical trial Recruiting at 6 sites Observational Ages Any age to 21

Examining health outcomes in children with congenital heart disease undergoing non-cardiac procedures

Official title: Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures

Run by Boston Children's Hospital · NCT04604418 · Data updated 2026-11-12

This study looks at how children with congenital heart disease do during and after non-heart surgeries to help doctors provide better care for them.

More Congenital Heart Disease trials

Quick facts

Study typeObservational
AgesAny age to 21 Years
SexAll
Enrollment10000 (estimated)
SponsorBoston Children's Hospital
Academic / other
Locations10 sites (Los Angeles, California and 9 other locations)
StatusRecruiting
StartedOctober 1, 2020
Main results expectedOctober 31, 2026
Study endsDecember 31, 2026
Registry record updatedApril 7, 2026
Trial IDNCT04604418 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are children aged birth to 21 years diagnosed with congenital heart disease who are scheduled for non-cardiac procedures.

Probably not a fit

Patients undergoing cardiac surgical procedures or catheterizations will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on children diagnosed with congenital heart disease (CHD) who are undergoing non-cardiac surgical or nonsurgical procedures. It aims to analyze health care resource utilization and outcomes in this population, given the increasing prevalence of CHD due to improved survival rates. By utilizing data from multiple prominent medical centers, the study seeks to provide insights into perioperative risks and adverse postoperative outcomes for these patients. The findings could help inform anesthesiologists and pediatricians in managing care for children with CHD during non-cardiac procedures.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of perioperative risks in children with CHD, leading to improved patient management and outcomes.

How similar studies have gone: While there is limited data on similar observational studies, the increasing focus on perioperative outcomes in pediatric populations suggests potential for meaningful insights.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Males or females ages birth to 21 years.
2. Patients diagnosed with congenital heart disease
3. Patients undergoing a noncardiac procedure (surgical or nonsurgical)

Exclusion Criteria:

1. Patients with congenial heart disease undergoing a cardiac surgical procedure including pacemakers.
2. Patients with congenital heart disease undergoing a catheterization(diagnostic or interventional) or an electrophysiology study

Where it's running

  • Children's National Medical Center
    Washington D.C., District of Columbia, United States     Recruiting
  • Boston Children's Hospital
    Boston, Massachusetts, United States     Recruiting
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania, United States     Recruiting
  • Vanderbilt University Medical Center
    Nashville, Tennessee, United States     Recruiting
  • Texas Children's Hospital
    Houston, Texas, United States     Recruiting
  • Hospital for Sick Kids
    Toronto, Ontario, Canada     Recruiting
Show 4 more locations
  • University of California, Los Angeles
    Los Angeles, California, United States     Active not recruiting
  • Children's Healthcare of Atlanta - Egleston Hospita
    Atlanta, Georgia, United States     Active not recruiting
  • University of Minnesota Medical Center
    Minneapolis, Minnesota, United States     Active not recruiting
  • Children's Hospital of the King's Daughter
    Norfolk, Virginia, United States     Terminated

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Congenital Heart Disease in Children 6Boston Children's Hospital 962
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.