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

Recruiting now · Not applicable

Conditions studied: Congenital Heart Disease

In brief

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 facts

Study ID

NCT03891160

Run by

Columbia University

People needed

36

Starts

2020-01-22

Expected to finish

2027-07-31

Last updated by the study team

2025-10-10

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• University of Florida — Gainesville, Florida, United States (enrolling)
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States (enrolling)
• Lurie Children's Hospital — Chicago, Illinois, United States (enrolling)
• Columbia University — New York, New York, United States (enrolling)
• Weill Cornell — New York, New York, United States

Full record on ClinicalTrials.gov

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