Actively Recruiting

Phase Not Applicable
All Genders
NCT03891160

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

Led by Columbia University · Updated on 2025-10-10

36

Participants Needed

5

Research Sites

392 weeks

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who weigh over 3 kilograms with CHD HF who are candidates for MCS will be prospectively identified at the participating centers.
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 5 locations

1

University of Florida

Gainesville, Florida, United States, 32610

Actively Recruiting

2

Children's Healthcare of Atlanta

Atlanta, Georgia, United States, 30322

Actively Recruiting

3

Lurie Children's Hospital

Chicago, Illinois, United States, 60611

Actively Recruiting

4

Columbia University

New York, New York, United States, 10032

Actively Recruiting

5

Weill Cornell

New York, New York, United States, 10065

Not Yet Recruiting

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Research Team

K

Kanwal Farooqi, MD

CONTACT

K

Katrina Golub, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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