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3D Heart Models for Congenital Heart Disease (IMMPACT Trial)

N/A
Recruiting
Led By Kanwal Farooqi, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who weigh over 3 kilograms with CHD HF who are candidates for MCS will be prospectively identified at the participating centers.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 year
Awards & highlights

IMMPACT Trial Summary

This trial will compare kids who have a 3D printed heart model before VAD surgery to those who don't, to see if the models improve patient outcomes.

Who is the study for?
This trial is for children over 3 kilograms with Congenital Heart Disease (CHD) and heart failure who are candidates for mechanical circulatory support. It's not suitable for those unable to tolerate a cardiac MRI or CT scan.Check my eligibility
What is being tested?
The study is examining the benefits of using a personalized 3D printed model of the heart to plan surgeries involving ventricular assist device placement in kids with CHD, compared to planning without it.See study design
What are the potential side effects?
Since this trial involves non-invasive pre-surgical planning with a 3D heart model, there are no direct side effects from the intervention itself.

IMMPACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I weigh more than 3 kilograms and am a candidate for a mechanical circulatory support device due to heart failure.

IMMPACT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
A change in the clarity of cannula and VAD site demonstration
Improvement in cardiopulmonary bypass time

IMMPACT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group A - 3D modelsExperimental Treatment1 Intervention
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.
Group II: Group B - ControlActive Control1 Intervention
Group B will be the controls and will not receive a 3D model.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,426 Previous Clinical Trials
2,473,764 Total Patients Enrolled
Kanwal Farooqi, MDPrincipal InvestigatorColumbia University

Media Library

3D model of heart 2023 Treatment Timeline for Medical Study. Trial Name: NCT03891160 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there more than one research center in Canada running this investigation?

"This trial is offered in 19 different sites, including Duke University, Montreal Heart Institute and Montefiore Medical Center. Additionally, there are 16 other centres available for participation."

Answered by AI

How many individuals have signed up to participate in this experiment?

"This trial requires 44 volunteers, who meet the necessary inclusion criteria, to sign up. There are multiple sites available for participation, including Duke University in Durham and Montreal Heart Institute in Montreal."

Answered by AI

Are patient enrolments for this research endeavor currently available?

"Yes, the data hosted on clinicaltrials.gov indicates that this medical investigation is still accepting participants. This trial was initially posted in January of 2020 and recently updated in August 2022; it requires 44 individuals to be enrolled across 19 distinct locations."

Answered by AI
~11 spots leftby Jul 2025