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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
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 Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 year
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Congenital Heart Disease (CHD) include surgical interventions, catheter-based procedures, and pharmacotherapy. Surgical interventions, such as ventricular assist device (VAD) placement, correct structural abnormalities and improve heart function.
Catheter-based procedures, like balloon angioplasty and stent placement, help to open narrowed blood vessels and improve blood flow. Pharmacotherapy, including medications like diuretics and beta-blockers, manage symptoms and prevent complications.
Enhanced surgical planning using 3D printed heart models allows for precise visualization of the patient's unique anatomy, leading to more accurate and effective surgical outcomes. This is crucial for CHD patients as it reduces the risk of complications and improves overall prognosis.
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,443 Previous Clinical Trials
2,451,953 Total Patients Enrolled
Kanwal Farooqi, MDPrincipal InvestigatorColumbia University
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Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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