What this study is
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.
What's being tested
- 3D model of heart
Intervention · 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
- Sponsor
- Columbia University
- Conditions
- Congenital Heart Disease
- Enrolling
- 36 people
- Starts
- 2020-01-22
- Est. completion
- 2027-07-31
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Sex ALLHealthy volunteers Not acceptedYou 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 can't join if
- Any CHD-HF patient unable to tolerate a CMR or cardiac CT will be excluded.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (6)
6 openStanford University
Palo Alto, California, United States
- Sujatha Buddhe, MD · Contactsujatha.buddhe@stanford.edu
- Kifle Yohannes · Contactkifley@stanford.edu
RecruitingUniversity of Florida
Gainesville, Florida, United States
- Jeffrey Jacobs, MD · Contactjeffreyjacobs@ufl.edu
- Jeffrey Jacobs, MD · Principal investigator
RecruitingChildren's Healthcare of Atlanta
Atlanta, Georgia, United States
- Fawwaz Shaw, MD · Contactfawwaz.shaw@choa.org
- Fawwaz Shaw, MD · Principal investigator
RecruitingLurie Children's Hospital
Chicago, Illinois, United States
- Michael Monge, MD · Contactmmonge@luriechildrens.org
- Michael Monge, MD · Principal investigator
RecruitingColumbia University
New York, New York, United States
- Kanwal Farooqi, MD · Contact212-342-1562kf2549@cumc.columbia.edu
RecruitingWeill Cornell
New York, New York, United States
- Yoshifumi Naka, MD · Contactnakayos@med.cornell.edu
- Yoshifumi Naka, MD · Principal investigator
Not yet recruiting
Study team
Sponsor
Columbia University
Study ID AAAR7877
Principal investigator
Kanwal Farooqi, MD
Columbia University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.