Recruiting

Mechanical Circulatory Support

Sponsor:

Columbia University

Code:

NCT03891160

Conditions

Congenital Heart Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

3D model of heart

Study Details

Brief 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.

Conditions

Congenital Heart Disease

Study ID

NCT03891160

Start date

Jan 22, 2020

Status verified date

Oct, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Group A - 3D models

Group A will receive 3-D printed models will be used for pre-VAD planning. For patients in Group A, the surgeon will complete a questionnaire 1) after reviewing 2D imaging data and 2) after reviewing a patient specific 3D model. The investigators primary outcome measure will be an improvement in the clarity of cannula and VAD site demonstration. The investigators hypothesize that the 3D models will more clearly demonstrate the sites of cannula and VAD placement as compared to 2D imaging.

no intervention: Group B - Control

Group B will be the controls and will not receive a 3D model.

Interventions

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).

Primary outcome measure

  • A change in the clarity of cannula and VAD site demonstration [ Time Frame: 30 day ]
  • Improvement in cardiopulmonary bypass time [ Time Frame: 5 year ]

Central Contacts and Locations

Central contacts

Kanwal Farooqi, MD

212-305-8509kf2549@cumc.columbia.edu

Katrina Golub, MPH

212-342-1562kg2697@cumc.columbia.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Jeffrey Jacobs, MD

jeffreyjacobs@ufl.edu

Principal Investigator:

Jeffrey Jacobs, MD

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Fawwaz Shaw, MD

fawwaz.shaw@choa.org

Principal Investigator:

Fawwaz Shaw, MD

Lurie Children's Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Michael Monge, MD

mmonge@luriechildrens.org

Principal Investigator:

Michael Monge, MD

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Kanwal Farooqi, MD

212-342-1562kf2549@cumc.columbia.edu

More Information

Sponsor

Columbia University

Last update posted

Oct 10, 2025

Last verified

Oct, 2025

Keywords

  • Congenital Heart Disease (CHD)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Columbia University on 2025-10-10.