Ventripoint Echocardiography for Single Ventricle Heart

Overseen By Joan Wilson

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Congenital heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new 3D heart imaging technique called the Ventripoint Echocardiogram. The goal is to evaluate how well this technique assesses heart size and function in children and young adults with a functional single ventricle, a condition where one of the heart's pumping chambers is underdeveloped or missing. Participants will undergo both the Ventripoint 3D Echo and other standard heart imaging tests, such as an ultrasound or MRI. The trial seeks individuals with a functional single ventricle who are already scheduled for one of these standard heart imaging tests. As an unphased trial, it offers a unique opportunity to advance heart imaging techniques for improved diagnosis and care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this echocardiographic technique is safe for assessing cardiac size and function?

A previous study showed that the Ventripoint Echocardiogram system, or VMS+, meets safety standards for medical devices. This indicates it has been tested and is deemed safe and reliable for healthcare use. The system creates 3D images of the heart, aiding doctors in understanding its size and function.

VMS+ provides detailed pictures of all four heart chambers by converting 2D images into a 3D model. This non-invasive technology does not involve surgery or entering the body. Safety reports for VMS+ do not mention any serious side effects, suggesting it is well-tolerated.

Overall, based on existing studies and its use in medical practice, the Ventripoint Echocardiogram system is considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Ventripoint 3D Echocardiography because it offers a novel way to assess heart function in patients with single ventricle conditions, using advanced 3D technology. Unlike traditional methods like Transthoracic Echocardiograms or Cardiac MRIs, which can be time-consuming and less detailed, Ventripoint's system provides a quick, comprehensive view of the heart's structure and function. This innovative approach could lead to more accurate diagnoses and better management of single ventricle heart conditions, ultimately improving patient outcomes.

What evidence suggests that the Ventripoint Echocardiogram is effective for assessing single ventricle heart conditions?

Research has shown that the Ventripoint Echocardiogram, one of the treatments studied in this trial, can create a 3D image of the heart using a regular 2D heart scan. This technology provides detailed heart measurements similar to those from an MRI. Studies have found that it accurately assesses heart size and function in patients with single ventricles. This is important because it offers a less invasive and more accessible way to evaluate heart health compared to traditional methods. Early findings suggest that this technique could enhance understanding of heart conditions in people with complex heart structures. Participants in this trial will receive either the Ventripoint Echocardiogram, a Transthoracic Echocardiogram, or a Cardiac MRI for comparison. ^{2 6 7 8 9}

Who Is on the Research Team?

Piers Barker, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have a single functioning ventricle and need an echocardiogram or MRI.

Exclusion Criteria

I understand and can consent in English.

You have a heart condition that is not a functional single ventricle.

You have a specific type of heart condition called single ventricle physiology, but not single ventricle anatomy following a specific type of heart surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Initial assessment using Ventripoint 3D Echocardiogram and comparison with Transthoracic Echocardiogram or Cardiac MRI

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after baseline assessment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transthoracic Echocardiogram or Cardiac MRI
• Ventripoint Echocardiogram

Trial Overview

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.

How Is the Trial Designed?

Group I: Ventripoint 3D Echocardiogram Experimental Treatment 1 Intervention

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

Group II: Transthoracic Echocardiogram or Cardiac MRI Active Control 1 Intervention

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

Ventripoint Echocardiogram is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Ventripoint Medical System Plus for:

• Cardiac size and function assessment in children and young adults with functional single ventricles
• Congenital heart defects

Approved in United States as Ventripoint Medical System Plus for:

• Cardiac size and function assessment in children and young adults with functional single ventricles
• Pulmonary hypertension

Approved in Canada as Ventripoint Medical System Plus for:

• Cardiac size and function assessment in children and young adults with functional single ventricles
• Congenital heart defects

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

The EchoNavigator (EchoNav) system enhances the precision and accuracy of interventional cardiac procedures by fusing live X-ray images with three-dimensional transesophageal echocardiogram (TEE) images.

In a case study of balloon mitral valvuloplasty, the use of EchoNav 3.0.2 improved procedural safety by better visualizing the relationship between interventional tools and surrounding cardiac structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fusion imaging during balloon mitral valvulopasty: First experience. Hudson, O., Prejean, SP., Von Mering, G., et al.[2021]

The EchoNavigator system (EchoNav II) allows for real-time fusion of echocardiographic and fluoroscopic images, proving to be as safe as traditional methods for transseptal puncture (TSP) during procedures like MitraClip implantation and left atrial appendage closure.

The use of EchoNav II significantly reduced the time required to perform TSP, with an average time of 18.48 minutes compared to 23.20 minutes using standard methods, indicating improved efficacy in the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of transseptal puncture guided by real-time fusion of echocardiography and fluoroscopy. Afzal, S., Veulemans, V., Balzer, J., et al.[2020]

Echocardiographic 3D-guided 2D planimetry significantly enhances the accuracy of assessing left-sided valvular heart disease, particularly for measuring mitral valve area in rheumatic mitral valve stenosis and vena contracta area in mitral regurgitation.

This method has shown excellent feasibility, reproducibility, and time efficiency in studies, making it a valuable clinical tool for quantifying mitral valve disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Echocardiographic 3D-guided 2D planimetry in quantifying left-sided valvular heart disease. Argulian, E., Seetharam, K.[2018]

Three-dimensional echocardiography significantly enhances the understanding of mitral valve mechanics, which can improve diagnosis and treatment strategies for mitral valve disease.

This advanced imaging technique offers advantages over traditional 2D echocardiography, aiding in surgical planning and evaluation of outcomes, thus potentially leading to better patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional echocardiography of the mitral valve: lessons learned. Maffessanti, F., Mirea, O., Tamborini, G., et al.[2021]

In a study involving 23 heart failure patients and 16 normal controls, high-resolution real-time 3D echocardiography (RT3DE) demonstrated a significantly higher level of left ventricular asynchrony in heart failure patients compared to controls, indicating its potential for assessing heart function.

The study found a strong correlation between the asynchrony measurements from RT3DE and tissue Doppler imaging (TDI), suggesting that RT3DE could serve as an effective alternative method for evaluating left ventricular asynchrony in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of left ventricular asynchrony using volume-time curves of 16 segments by real-time 3 dimensional echocardiography: comparison with tissue Doppler imaging. Park, SM., Kim, KC., Jeon, MJ., et al.[2016]

The use of echocardiography before, during, and after surgery has significantly improved patient outcomes in those with congenital heart disease by allowing for precise evaluations and timely interventions.

This comprehensive approach helps in making better decisions regarding treatment and in identifying any remaining issues after surgery, ultimately enhancing patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative echocardiographic evaluation. Williams, RG.[2019]

In a study of 39 single-ventricle patients who underwent multiple surgeries between 1996 and 2008, early surgical correction of atrioventricular valve regurgitation (AVVR) showed a tendency for improved valve function during follow-up, although the results were not statistically significant.

Patients with a preoperative AVVR grade of less than 2 did not experience worsening of their condition post-surgery, suggesting that early intervention may help maintain better cardiac function in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early surgical correction of atrioventricular valvular regurgitation in single-ventricle patients. Kwak, JG., Park, CS., Lee, CH., et al.[2010]

A new computerized software program for archiving and reporting echocardiographic studies has been developed to standardize echo reports across different laboratories in Italy, enhancing data collection for epidemiological and scientific purposes.

The program includes a comprehensive database with 733 variables for resting echocardiography and varying numbers for stress tests, and it was successfully tested with 291 resting and 56 stress echocardiographic studies, marking a significant advancement in cardiology data management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Reporting echocardiography exams with the G8-Cardio ANMCO software]. Badano, LP., Marchesini, A., Pizzuti, A., et al.[2006]

In a study comparing two techniques for measuring mitral valve areas (MVAs) in patients who underwent mitral valve repair surgery, the 3D planimetry technique yielded larger MVA measurements than the pressure half-time (PHT) technique, suggesting differences in how these methods assess valve size.

Despite the larger measurements from the 3D planimetry technique, the study found that the PHT technique had better correlation and precision, indicating that caution is needed when interpreting MVA results from different echocardiographic techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of mitral valve area with echocardiography, using intra-operative 3-dimensional versus intra- & post-operative pressure half-time technique in mitral valve repair surgery. Kang, WS., Choi, JW., Kang, JE., et al.[2021]

New echocardiographic techniques, like tissue Doppler and strain imaging, along with cardiac magnetic resonance imaging and biomarkers such as B-type natriuretic peptide, can help accurately assess heart valve disease severity and patient symptoms.

These advanced assessment methods may identify patients at higher risk for worsening symptoms or adverse events, potentially improving the timing of surgery and overall patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel methods to assess heart valve disease. To, AC., Stewart, RA.[2009]

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