Ventripoint Echocardiography for Single Ventricle Heart
Palo Alto (17 mi)Overseen byPiers Barker, MD
Age: Any Age
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Duke University
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.
What data supports the idea that Ventripoint Echocardiography for Single Ventricle Heart is an effective treatment?The available research does not directly provide data on the effectiveness of Ventripoint Echocardiography for Single Ventricle Heart. However, it highlights the benefits of using advanced echocardiography techniques, like 3D echocardiography, in understanding heart conditions and improving surgical outcomes. For example, 3D echocardiography has been shown to enhance the diagnosis and treatment planning for mitral valve issues, which suggests that similar advanced imaging techniques could be beneficial for single ventricle heart conditions. This implies that Ventripoint Echocardiography, which uses advanced imaging, might also be effective in providing detailed heart assessments and aiding in treatment decisions.14569
Is the treatment Ventripoint Echocardiogram a promising treatment for single ventricle heart?Yes, the Ventripoint Echocardiogram is a promising treatment because it uses advanced 3D imaging to provide accurate and detailed heart assessments, which can improve the precision and safety of heart procedures.38101213
What safety data exists for Ventripoint Echocardiography in single ventricle heart treatment?The provided research does not contain specific safety data for Ventripoint Echocardiography or its related names like Transthoracic Echocardiogram, Cardiac MRI, or VMS+. The studies focus on the MitraClip system for valve repair and nomenclature for single ventricle hearts, but do not address the safety of Ventripoint Echocardiography.2671114
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
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.Exclusion Criteria
I understand and can consent in English.
Treatment Details
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.
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.
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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Duke UniversityDurham, NC
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Who is running the clinical trial?
Duke UniversityLead Sponsor
References
Perioperative echocardiographic evaluation. [2019]The integration of pre-, intra- and postoperative echo-cardiography has advanced the health of patients with congenital heart disease by providing an accurate initial evaluation, improving the timing and choice of intervention and detecting residual abnormalities in a timely fashion.
Congenital Heart Surgery Nomenclature and Database Project: single ventricle. [2019]The extant nomenclature for single ventricle (SV) hearts is reviewed for the purpose of establishing a unified reporting system. The subject was debated and reviewed by members of the STS-Congenital Heart Surgery Database Committee and representatives from the European Association for Cardiothoracic Surgery. Efforts were made to include all relevant nomenclature categories using synonyms where appropriate. Although many issues regarding single ventricle or univentricular hearts remain unresolved among anatomists and pathologists, a classification is proposed that is relevant to surgical therapy. A comprehensive database set is presented, which is based on a hierarchical scheme. Data are entered at various levels of complexity and detail, which can be determined by the clinician. These data can lay the foundation for comprehensive risk stratification analyses. A minimum data set is also presented that will allow for data sharing and would lend itself to basic interpretation of trends. Outcome tables relating diagnoses, procedures, and various risk factors are presented.
[Reporting echocardiography exams with the G8-Cardio ANMCO software]. [2006]The availability of a common computerized program for echocardiographic study archiving and reporting at national and/or international level could make it possible to standardize the echo reports of different echocardiographic laboratories, and to use the wealth of data thus obtainable with echocardiography, and to exploit its capillary territorial distribution, with the aim of collecting echocardiographic data in a standard format for epidemiological, scientific and administrative purposes.
Assessment of left ventricular asynchrony using volume-time curves of 16 segments by real-time 3 dimensional echocardiography: comparison with tissue Doppler imaging. [2016]Recent technical developments with high-resolution real-time 3 dimensional echocardiography (RT3DE) facilitate the acquisition of high quality images and the analysis of segmental volume-time curves (VTCs).
Novel methods to assess heart valve disease. [2009]Optimal timing of surgery for heart valve disease relies on the accurate assessment of symptoms, lesion severity, cardiac function and the risks of disease progression. Recent studies suggest potential roles for new echocardiographic techniques, including tissue Doppler and strain imaging at rest or after exercise stress, cardiac magnetic resonance imaging and biomarkers such as B-type natriuretic peptide. These techniques may identify patients at higher risk of symptomatic deterioration or adverse clinical events, and improve the cost-effectiveness and reliability of follow-up.
Early surgical correction of atrioventricular valvular regurgitation in single-ventricle patients. [2010]The purpose of this study is to evaluate the effectiveness of early surgical correction for atrioventricular valve regurgitation (AVVR) in single-ventricle patients.
Percutaneous mitral valve repair in patients with prior cardiac surgery. [2016]The safety of percutaneous mitral valve repair with the MitraClip system has been documented. However, few data are available on high-risk patients not amenable to surgery. The aim of this study was to evaluate the outcomes of patients with prior cardiac surgery undergoing MitraClip therapy (Abbott, Abbott Park, Chicago, IL, USA) for severe mitral regurgitation.
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]We hypothesized that mitral valve areas (MVAs) with echocardiography, using 3D planimetry technique (measured at one point at maximal opening of mitral valve) versus pressure half-time technique (PHT, measured during entire diastolic phase) in mitral valve repair surgery (MVR) would be different.
Three-dimensional echocardiography of the mitral valve: lessons learned. [2021]Three-dimensional echocardiography has markedly improved our understanding of normal and pathologic mitral valve (MV) mechanics. Qualitative and quantitative analysis of three-dimensional (3D) data on the mitral valve could have a clinical impact on diagnosis, patient referral, surgical strategies, annuloplasty ring design and evaluation of the immediate and long-term surgical outcome. This review covers the contribution of 3D echocardiography in the diagnosis of MV disease, its role in selecting and monitoring surgical procedures, and in the assessment of surgical outcomes. Moreover, advantages of this technique versus the standard 2D modality, as well as future applications of advanced analysis techniques, will be reviewed.
Safety and efficacy of transseptal puncture guided by real-time fusion of echocardiography and fluoroscopy. [2020]Visual guidance through echocardiography and fluoroscopy is crucial for a successful transseptal puncture (TSP) in a prespecified region of the fossa ovalis. The novel EchoNavigator system Release II (EchoNav II, Philips Healthcare, Andover, Massachusetts, USA) enables the real-time fusion of fluoroscopic and echocardiographic images. We evaluated this new imaging method in respect to safety and efficacy of TSP during MitraClip implantation and left atrial appendage closure.
Current status of MitraClip for patients with mitral and tricuspid regurgitation. [2018]Mitral valve regurgitation (MR) affects approximately 4 million people in the United States alone, increasing in prevalence with age. Approved by the Food and Drug Administration (FDA) in October 2013, percutaneous edge-to-edge transcatheter mitral valve repair (also known as the MitraClip system) has been used in over 40,000 patients globally. Additionally, there is keen interest and early exploration into the use of MitraClip for treatment of severe symptomatic tricuspid regurgitation, another undertreated disease with significant morbidity and mortality. In this manuscript, we aim to review the current indications, procedural details as well as emerging indications for this novel technology.
Echocardiographic 3D-guided 2D planimetry in quantifying left-sided valvular heart disease. [2018]Echocardiographic 3D-guided 2D planimetry can improve the accuracy of valvular disease assessment. Acquisition of 3D pyramidal dataset allows subsequent multiplanar reconstruction with accurate orthogonal plane alignment to obtain the correct borders of an anatomic orifice or flow area. Studies examining the 3D-guided 2D planimetry approach in left-sided valvular heart disease were identified and reviewed. The strongest evidence exists for estimating mitral valve area in patients with rheumatic mitral valve stenosis and vena contracta area in patients with mitral regurgitation (both primary and secondary). 3D-guided approach showed excellent feasibility and reproducibility in most studies, as well as time efficiency and good correlation with reference and comparator methods. Therefore, 3D-guided 2D planimetry can be used as an important clinical tool in quantifying left-sided valvular heart disease, especially mitral valve disorders.
Fusion imaging during balloon mitral valvulopasty: First experience. [2021]The EchoNavigator (EchoNav, Philips, The Netherlands) is a tool that fuses live X-ray with three-dimensional (3D) transesophageal echocardiogram (TEE) images allowing for enhanced precision and accuracy during interventional cardiac procedures. We present the first case of EchoNav utilization during balloon mitral valvuloplasty using the newest version (EchoNav 3.0.2). The benefits of the EchoNav application include improved procedural precision and safety due to improved demonstration of the relationship between the interventional equipment and neighboring cardiac structures.
Tricuspid clip implantation using the MitraClip system-A step-by-step guide. [2022]Many novel percutaneous interventions are being developed for application in the tricuspid valve position. At the present time, there are no commercially available devices for this application. There has been mounting evidence supporting the safety and efficacy of using the MitraClip system on the tricuspid valve. This review summarizes the peer reviewed data available to date supporting this procedure, outlines the step-by-step maneuvers using the MitraClip system for this application, and imaging techniques used prior to and during the procedure.