Ventripoint Echocardiography for Single Ventricle Heart

Recruiting in Palo Alto (17 mi)

Overseen by Piers Barker, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Duke University

Disqualifiers: Congenital heart disease, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of this treatment for single ventricle heart conditions?

The use of three-dimensional echocardiography has improved the understanding and evaluation of heart valve conditions, which can aid in better diagnosis and treatment planning for heart issues, including those in single-ventricle patients. ^{1 2 3 4 5}

How is the Ventripoint Echocardiogram treatment different from other treatments for single ventricle heart conditions?

The Ventripoint Echocardiogram is unique because it uses a 3D Echo software application to provide detailed images of the heart, which can improve the accuracy of heart assessments compared to traditional 2D echocardiography. This advanced imaging technique allows for better visualization and understanding of complex heart structures, which is particularly beneficial for conditions like single ventricle heart. ^{6 7 8 9 10}

Research Team

Piers Barker, MD

Principal Investigator

Duke University

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Transthoracic Echocardiogram or Cardiac MRI (Imaging)
• Ventripoint Echocardiogram (Imaging)

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.

Participant Groups

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 Canada for the following indications:

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+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Perioperative echocardiographic evaluation. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Three-dimensional echocardiography of the mitral valve: lessons learned. [2021]

3. England 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. [2016]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Early surgical correction of atrioventricular valvular regurgitation in single-ventricle patients. [2010]

5. England pubmed.ncbi.nlm.nih.gov

Novel methods to assess heart valve disease. [2009]

6. United States pubmed.ncbi.nlm.nih.gov

Fusion imaging during balloon mitral valvulopasty: First experience. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Echocardiographic 3D-guided 2D planimetry in quantifying left-sided valvular heart disease. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and efficacy of transseptal puncture guided by real-time fusion of echocardiography and fluoroscopy. [2020]

9. Italy pubmed.ncbi.nlm.nih.gov

[Reporting echocardiography exams with the G8-Cardio ANMCO software]. [2006]

10. England 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. [2021]