What side effects are associated with this type of intervention?

Common treatments for Congenital Heart Disease (CHD) that involve surgical interventions, such as ventricular assist device (VAD) placement and other corrective heart surgeries, can have several side effects. These may include infection, bleeding, blood clots, and complications related to anesthesia. Additionally, there can be risks of arrhythmias, heart failure, and issues related to the mechanical function of implanted devices. The use of advanced techniques like 3D printed heart models aims to enhance surgical planning and potentially reduce these risks by providing more precise anatomical details.

What prior FDA approvals exist?

The FDA has approved various treatments for Congenital Heart Disease (CHD), including surgical interventions and pharmacological therapies. While specific FDA approvals for treatments directly involving 3D printed heart models are not detailed, the use of 3D printing technology in surgical planning for CHD is an emerging field. This innovative approach aims to improve patient outcomes by providing detailed anatomical models that help surgeons plan complex procedures more effectively. Traditional treatments for CHD often involve surgical correction, and the integration of 3D printed models represents a significant advancement in pre-surgical assessment and planning.

What other types of research exist?

Promising novel alternatives to 3D printed heart models for congenital heart disease patients include virtual reality (VR) and augmented reality (AR) surgical planning tools, which allow for immersive visualization and interaction with patient-specific anatomy. Additionally, advanced imaging techniques such as 4D flow MRI and computational fluid dynamics (CFD) simulations can provide detailed insights into cardiovascular dynamics, aiding in pre-surgical planning and decision-making.

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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

Must not have

Any CHD-HF patient unable to tolerate a CMR or cardiac CT will be excluded.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 year

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the use of 3D printed heart models to help plan surgeries for children with complex congenital heart disease and heart failure. The models aim to give doctors a better understanding of the patient's heart, potentially leading to safer and more effective surgeries. 3D printing technology is emerging as a potential new tool for planning medical interventions, particularly in congenital heart disease settings.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I can undergo CMR or cardiac CT scans without issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

A change in the clarity of cannula and VAD site demonstration

Improvement in cardiopulmonary bypass time

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 1Eligibility criteria met

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.