Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart Disease Treatment
IMMPACT
2 other identifiers
interventional
36
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2019
CompletedFirst Posted
Study publicly available on registry
March 26, 2019
CompletedStudy Start
First participant enrolled
January 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
October 10, 2025
October 1, 2025
7.5 years
March 18, 2019
October 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
A change in the clarity of cannula and VAD site demonstration
Change in survey responses regarding clarity of VAD or cannula site placement.
30 day
Improvement in cardiopulmonary bypass time
Detecting a change in cardiopulmonary bypass time in patients in the group that used the 3D models for pre-VAD planning.
5 year
Study Arms (2)
Group A - 3D models
EXPERIMENTALGroup 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.
Group B - Control
NO INTERVENTIONGroup B will be the controls and will not receive a 3D model.
Interventions
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).
Eligibility Criteria
You may qualify if:
- Patients who weigh over 3 kilograms with CHD HF who are candidates for MCS will be prospectively identified at the participating centers.
You may not qualify if:
- Any CHD-HF patient unable to tolerate a CMR or cardiac CT will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University of Florida
Gainesville, Florida, 32610, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Lurie Children's Hospital
Chicago, Illinois, 60611, United States
Columbia University
New York, New York, 10032, United States
Weill Cornell
New York, New York, 10065, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kanwal Farooqi, MD
Columbia University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics
Study Record Dates
First Submitted
March 18, 2019
First Posted
March 26, 2019
Study Start
January 22, 2020
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
October 10, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share