πŸ›οΈ Verified NIH Record β€’ Updated 2025-10-08

Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart Disease Treatment (NCT03891160)

🟒 Recruiting Observational / Diagnostic πŸ“‹ Clinical Research Protocol Sponsor: Columbia University

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this research study is to look at the advantages of using a 3D printed heart model for surgical planning in children who have been diagnosed with Congenital Heart Disease (CHD) and clinical heart failure and will undergo a ventricular assist device (VAD) placement. The investigators want to study the correlation of having a 3D printed model with improvement in patient outcomes and compare those with patients who have had a VAD placement without a 3D model.

Who can join: Review the eligibility criteria below.

Location: University of Florida β€” Gainesville, Florida

πŸ§ͺ Interventions in This Study

  • 3D model of heart (OTHER)

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (5 Sites)

  • University of Florida β€” Gainesville, Florida
  • Children's Healthcare of Atlanta β€” Atlanta, Georgia
  • Lurie Children's Hospital β€” Chicago, Illinois
  • Columbia University β€” New York, New York
  • Weill Cornell β€” New York, New York

πŸ“ž Contact the Study Coordinator

Phone: (212) 305-8509

Email: kf2549@cumc.columbia.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Congenital Heart Disease

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—