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RECRUITING
NCT03891160
NA

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

Sponsor: Columbia University

View on ClinicalTrials.gov

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

Interventions

OTHER

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