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3D Heart Models for Congenital Heart Disease Surgical Planning

This study is looking at how using a 3D printed model of the heart can help doctors plan surgery for children with Congenital Heart Disease (CHD) and heart failure. These children are candidates for a ventricular assist device (VAD) placement, which is a mechanical pump that helps the heart. Researchers want to see if using a 3D model improves how clearly doctors can see where to place the VAD and its tubes (cannulas) compared to standard 2D imaging. They will compare outcomes in patients who have a VAD placed with and without the help of a 3D model. You may be able to join if you weigh over 3 kilograms, have CHD and heart failure, and are considered for a VAD. The study is currently unclear on its recruitment status.

Study design
This study will involve 36 participants and will compare the use of 3D printed heart models against standard 2D imaging for surgical planning.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The clarity of cannula and VAD site demonstration will be measured at 30 days, and improvement in cardiopulmonary bypass time will be measured at 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03891160

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

Recruiting
NAAll AgesInterventionalDiagnostic
Columbia University
~36 participants
Updated 2025-10-10 on ClinicalTrials.gov
What's tested:3D model of heart

At a glance

Recruiting sites
4 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
A change in the clarity of cannula and VAD site demonstration
Measured over 30 day
+1 more outcome measured

Conditions

Congenital Heart Disease

Explore related trials

Congenital Heart DiseaseHeart Failure

NCT03891160

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's Healthcare of Atlanta

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • Columbia University

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Lurie Children's Hospital

    Chicago, Illinoisstudy coordinator listed

    Recruiting

  • University of Florida

    Gainesville, Floridastudy coordinator listed

    Recruiting

  • Weill Cornell

    New York, New Yorkstudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Kanwal Farooqi, MD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

Kanwal Farooqi, MD
[email protected]
212-305-8509
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • A change in the clarity of cannula and VAD site demonstration30 day

    Change in survey responses regarding clarity of VAD or cannula site placement.

  • Improvement in cardiopulmonary bypass time5 year

    Detecting a change in cardiopulmonary bypass time in patients in the group that used the 3D models for pre-VAD planning.