No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
36 (estimated)
Sponsor
Columbia University · Other
Who this trial is looking for
This trial is looking for children with Congenital Heart Disease who are going to have a ventricular assist device (VAD) placed. Participants will help researchers understand if using a 3D model of their heart can improve surgery outcomes.
Are You a Good Fit for This Trial?
You may be able to join if
I weigh over 3 kilograms.
I have been diagnosed with Congenital Heart Disease.
I have heart failure.
I am a candidate for mechanical circulatory support.
You may not be able to join if
I cannot tolerate a CMR scan.
I cannot tolerate a cardiac CT scan.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 c…
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 Locations
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Eligibility Criteria
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.
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.
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