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Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart Disease Treatment
Sponsor: Columbia University
Summary
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.
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2020-01-22
Completion Date
2027-07-31
Last Updated
2025-10-10
Healthy Volunteers
No
Conditions
Interventions
3D model of heart
To assess if a 3D printed cardiac model improves visualization of VAD and cannula placement sites in CHD-HF patients as compared to 2D imaging. The investigators will prospectively enroll CHD-HF patients at multiple centers and randomize to group A (3D printed models will be used for pre-VAD planning) or Group B (controls).
Locations (5)
University of Florida
Gainesville, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Lurie Children's Hospital
Chicago, Illinois, United States
Columbia University
New York, New York, United States
Weill Cornell
New York, New York, United States