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

Key facts

Where
Atlanta, Chicago, Gainesville, New York, and Palo Alto, United StatesSee the 6 sites

Where in United States

  • Children's Healthcare of AtlantaAtlanta, United StatesContact: Fawwaz Shaw, MDTaking people
  • Lurie Children's HospitalChicago, United StatesContact: Michael Monge, MDTaking people
  • University of FloridaGainesville, United StatesContact: Jeffrey Jacobs, MDTaking people
  • Columbia UniversityNew York, United StatesContact: Kanwal Farooqi, MDTaking people
  • Weill CornellNew York, United StatesContact: Yoshifumi Naka, MDNot yet recruiting
  • Stanford UniversityPalo Alto, United StatesContact: Sujatha Buddhe, MDTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
Columbia University
Trial code
NCT03891160
Record updated
23 October 2026
Original description
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.Read full original descriptionShow less

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.

Inclusion: Patients who weigh over 3 kilograms with CHD HF who are candidates for MCS will be prospectively identified at the participating centers.

Exclusion: Any CHD-HF patient unable to tolerate a CMR or cardiac CT will be excluded.

ClinicalTrials.gov NCT03891160

Under construction, not live – Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart Disease Treatment (NCT03891160) – Frontlight Research