NCT03891160 Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart Disease Treatment
| NCT ID | NCT03891160 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Congenital Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2020-01-22 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2020-01-22 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Kanwal Farooqi, MD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT03891160 clinical trial?
This trial is open to participants of all sexes, studying Congenital Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03891160 currently recruiting?
Yes, NCT03891160 is actively recruiting participants. Contact the research team at kf2549@cumc.columbia.edu for enrollment information.
Where is the NCT03891160 trial being conducted?
This trial is being conducted at Gainesville, United States, Atlanta, United States, Chicago, United States, New York, United States and 1 additional location.
Who is sponsoring the NCT03891160 clinical trial?
NCT03891160 is sponsored by Columbia University. The principal investigator is Kanwal Farooqi, MD at Columbia University. The trial plans to enroll 36 participants.