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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Columbia University
Study ID
NCT03891160
Status
Recruiting
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Conditions

  • Congenital Heart Disease

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 3D model of heart — OTHER
    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).

Study Details

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 Dates

Start date
Jan 22, 2020
Status verified
Oct 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

A change in the clarity of cannula and VAD site demonstration [ Time Frame: 30 day ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Jeffrey Jacobs, MD
[email protected]
Jeffrey Jacobs, MD (PRINCIPAL_INVESTIGATOR)
Children's Healthcare of AtlantaAtlantaGeorgia30322
Fawwaz Shaw, MD
[email protected]
Fawwaz Shaw, MD (PRINCIPAL_INVESTIGATOR)
Lurie Children's HospitalChicagoIllinois60611
Michael Monge, MD
[email protected]
Michael Monge, MD (PRINCIPAL_INVESTIGATOR)
Columbia UniversityNew YorkNew York10032
Kanwal Farooqi, MD
[email protected]
212-342-1562
Weill CornellNew YorkNew York10065
Yoshifumi Naka, MD
[email protected]
Yoshifumi Naka, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Florida· Gainesville, FLChildren's Healthcare of Atlanta· Atlanta, GALurie Children's Hospital· Chicago, ILColumbia University· New York, NYWeill Cornell· New York, NY

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