What side effects are associated with this type of intervention?

The most common treatments for Single Ventricle Heart, particularly those involving advanced imaging techniques like coordinate-based 3-dimensional echocardiographic assessment, generally have minimal side effects. Patients may experience discomfort during the procedure and potential allergic reactions to contrast agents if used. Broader treatments for single ventricle conditions, which often include surgical interventions, can have side effects such as infection, arrhythmias, and complications related to heart function. Long-term management may also involve monitoring for heart failure and other cardiovascular issues.

What prior FDA approvals exist?

There is no specific mention of FDA-approved drugs or treatments for Single Ventricle Heart using coordinate-based 3-dimensional echocardiographic techniques in the provided context. However, the use of advanced imaging tools like 3D echocardiography is being explored for detailed cardiac assessment in children and young adults with functional single ventricles. This technique aims to improve the evaluation of cardiac size and function, potentially leading to better management and outcomes for patients with this condition.

What other types of research exist?

Promising alternatives to coordinate-based 3D echocardiographic techniques for single ventricle heart patients include advanced cardiac MRI, which offers high-resolution imaging and functional assessment without ionizing radiation, and point-of-care ultrasound techniques, such as 2D shear wave elastography, which provide real-time, detailed imaging of cardiac structures. Additionally, the integration of AI in imaging analysis is emerging as a powerful tool to enhance diagnostic accuracy and treatment planning.

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Imaging

Ventripoint Echocardiography for Single Ventricle Heart

N/A

Recruiting

Led By Piers Barker, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not have

Patients unable to understand or consent in English will be excluded.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new 3D ultrasound method to better measure heart size and function in children and young adults with single-ventricle hearts. Current methods struggle with accuracy due to the unique shapes of these hearts. The new technique uses coordinates to create detailed 3D images, aiming for more precise measurements.

Who is the study for?

This trial is for children and young adults with a type of heart disease known as functional single ventricles. Participants can be any age and at any stage of surgical treatment, provided they are undergoing or have undergone a clinically ordered echocardiogram or cardiac MRI.

What is being tested?

The study is testing the effectiveness of a new 3D echocardiographic technique called Ventripoint in assessing heart size and function compared to traditional transthoracic echocardiograms or cardiac MRIs in patients with single ventricle hearts.

What are the potential side effects?

Since this trial involves non-invasive imaging techniques like echocardiograms and MRIs, there are minimal side effects expected. The most common issues might include discomfort from lying still during the procedure or mild anxiety related to medical equipment.

Eligibility Criteria

Exclusion Criteria

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

Select...

I understand and can consent in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Cardiac function of the left ventricle as measured by ejection fraction

Cardiac function of the right ventricle as measured by ejection fraction

Left Ventricular Dimension as measured by end diastolic diameter

+11 more

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: Ventripoint 3D EchocardiogramExperimental Treatment1 Intervention

Ventripoint 3D Echo performed on subject to validate technology for use in single ventricle patients.

Group II: Transthoracic Echocardiogram or Cardiac MRIActive Control1 Intervention

Non-invasive imaging of the heart to evaluate structure and function.

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

The most common treatments for Single Ventricle Heart conditions include surgical interventions, medical management, and advanced imaging techniques. Surgical procedures, such as the Fontan operation, aim to optimize blood flow and reduce the workload on the single ventricle. Medical management often involves medications to manage symptoms and prevent complications. Advanced imaging techniques, like the coordinate-based 3-dimensional echocardiographic technique, provide detailed assessments of cardiac size and function. This is crucial for Single Ventricle Heart patients as it allows for precise monitoring and tailored treatment plans, improving outcomes and quality of life.