Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart Disease Treatment
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• Patients who weigh over 3 kilograms with CHD HF who are candidates for MCS will be prospectively identified at the participating centers.
Locations
United States
Florida
University of Florida
RECRUITING
Gainesville
Georgia
Children's Healthcare of Atlanta
RECRUITING
Atlanta
Illinois
Lurie Children's Hospital
RECRUITING
Chicago
New York
Columbia University
RECRUITING
New York
Weill Cornell
NOT_YET_RECRUITING
New York
Contact Information
Primary
Kanwal Farooqi, MD
kf2549@cumc.columbia.edu
212-305-8509
Backup
Katrina Golub, MPH
kg2697@cumc.columbia.edu
212-342-1562
Time Frame
Start Date: 2020-01-22
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 36
Treatments
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.
Authors
Related Therapeutic Areas
Sponsors
Leads: Columbia University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)