RecruitingNot ApplicableNCT03891160

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

Sponsor

Columbia University

Enrollment

36 participants

Start Date

Jan 22, 2020

Study Type

INTERVENTIONAL

Conditions

Congenital Heart Disease

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.

Eligibility

Inclusion Criteria1

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

Exclusion Criteria1

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

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Interventions

OTHER3D 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).