Novel 3-dimensional Echocardiographic Quantification of Mitral Regurgitant Volume
Conditions: Moderate or Severe Mitral Regurgitation
Sponsor: Germans Trias i Pujol Hospital

 
 
 
 
Novel 3-dimensional echocardiographic quantification of mitral 
regurgitant volume 
 
 
 
 
 
 
 
 
 
 
 
Document type: Study Protocol with SAP  
Document date: 02/02/2026 
 
 

 
 
 Research protocol version:  2.1  -  Date:  02/02/2026  
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STUDY TITLE 
Novel 3-dimensional echocardiographic quantification of mitral 
regurgitant volume  
 
STUDY CODE 
 
3D-CFQ-MR 
 
SPONSOR 
 
Hospital University Germans Trias i Pujol 
 
   
1. SUMMARY  
 
 
Study title 
 
Novel 
3-dimensional 
echocardiographic 
quantification of mitral regurgitant volume  
Background 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Quantification of mitral regurgitation remains 
challenging and yet is the main reason to perform or 
not a surgical or transcatheter intervention. Current 
methodology 
relies 
mainly 
on 
2-dimensional 
echocardiography, which is not ideal as it has many 
limitations: it assumes that the regurgitant orifice is 
circular, does not take into consideration the loading 
conditions or the flow status of the patient, and takes 
into consideration the maximum radius of the 
convergence zone at one single frame neglecting 
how that convergence zone changes along the 
cardiac 
systole. 
Accordingly, 
the 
current 
methodology leads frequently to underestimated 
effective regurgitant orifice area and regurgitant 
volume, has poor reproducibility and needs 
additional data to define the true grade of mitral 
regurgitation.  
Current technical developments have allowed the 3-
dimensional reconstruction of the convergence zone 
of the mitral regurgitant jet along the entire systole. 
This methodology is semiautomated, limiting the 
manipulation of the observer at minimum and 
therefore 
improving 
reproducibility 
of 
the 
measurement of regurgitant volume. The 3D-CFQ 
software (proprietary of Philips Ultrasound) has been 
used in limited cohort of patients and the 
comparison with 3-dimensional vena contracta area 
of the regurgitant jet as well as with cardiac magnetic 

 
 
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resonance-derived regurgitant volume has not been 
extensively evaluated. 
 
Hypothesis 
 
1.-The 3D-CFQ software provides better agreement 
with cardiac magnetic resonance to quantify mitral 
regurgitant 
volume 
from 
3-dimensional 
transesophageal echocardiography as compared to 
2-dimensional echocardiographic quantification of 
mitral regurgitant volume.  
2.-In 
addition, 
the 
correlation 
between 
3-
dimensional vena contracta area measured on 3-
dimensional 
echocardiographic 
data 
of 
the 
regurgitant jet and the regurgitant volume quantified 
with the novel 3D-CFQ software is better than the 
correlation with 2-dimensional effective regurgitant 
orifice area quantified with the proximal isovelocity 
surface area method.  
Endpoints 
 
1.-To demonstrate that 3D-CFQ software for the 
quantification of the mitral regurgitation is more 
reproducible and accurate than the conventional 
assessment of mitral regurgitation performed with 2-
dimensional echocardiography. 
2.-To demonstrate the agreement between 3D-CFQ 
measurement of the mitral regurgitant volume and 
the cardiac magnetic resonance measurement of the 
regurgitant volume is better than the agreement 
between 
2-dimensional 
echocardiography 
and 
cardiac magnetic resonance. 
Design 
 
Prospective 
acquisition 
of 
clinically 
acquired 
transesophageal echocardiographic and cardiac 
magnetic resonance data of the mitral regurgitation 
and retrospective analysis of the data.  
Study population 
 
Patients with at least moderate mitral regurgitation 
of any etiology who are referred for transesophageal 
echocardiographic evaluation. 
Number of patients 
 
 
At least 150 individuals will be included. 
Variables  
 
Demographic data include sex and age, and clinical 
data included cardiovascular risk factors, clinical 
symptoms 
and 
signs, 
laboratory 
data. 
Echocardiographic 
data 
(transthoracic 
and 
transoesophageal) and cardiac magnetic resonance 
data will be analysed using standard of care software 
and novel 3D-CFQ software.  
Data source 
 
Demographic and clinical data will be obtained 
retrospectively from electronic medical records. 

 
 
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Echocardiographic and cardiac magnetic resonance 
data will be acquired and stored in PACS. 
Medicinal product or medical device 
subject to evaluation (where 
applicable) 
3D-CFQ software 
Statistical analysis 
 
Categorical variables are presented as frequencies 
and percentages, and continuous variables are 
reported as mean ± standard deviation or median 
with interquartile range (IQR) according to the 
distribution of the variable. The Student T-test was 
used for comparison of continuous variables, and the 
Chi-square test was used to compared categorical 
variables. Correlations will be assessed with the 
Pearson test. Reproducibility data will be assessed 
with the intraclass correlation coefficients and the 
Bland-Altman plots. A p-value of <0.05 was 
considered statistically significant for all analyses. All 
statistical tests were two-sided. 
 
Milestones 
 
- 
12 
months 
for 
data 
Collection: 
Retrospective review of electronic medical 
records  
- 
4 Weeks for data Analysis: Statistical 
processing and evaluation  
- 
2 months for manuscript Preparation and 
Submission: Final study report preparation 
for publication in peer-reviewed medical 
journals 
 
 
 
 

 
 
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1. BACKGROUND 
 
A complete understanding of the etiology of mitral regurgitation (MR) is crucial for a correct 
diagnosis of valvular dysfunction, and consequently to define and plan the most appropriate 
therapeutic approach, either surgical or percutaneous. Two main mechanisms have been 
identified underlying MR (1): Primary or organic MR due to intrinsic involvement of mitral 
valve (MV) leaflets and chordae tendinae and secondary or functional MR caused by LV 
pathology. Another classification of mitral valve dysfunction based on leaflet motion was 
proposed by Carpentier et al in 1983 which is still widely used (2). According to this 
classification, type I MR is defined as normal leaflet motion, with annular dilatation (by LV or 
LA dilatation) or leaflet perforation (by endocarditis). Type II MR is characterized by excessive 
leaflet motion due to degenerative MV disease with chordal elongation or rupture and 
redundant leaflets, or to papillary muscle rupture (mainly ischemic origin). Finally, type III MR 
can be distinguished in 2 subtypes: type IIIa, with restricted leaflet motion both in systole and 
diastole related to leaflet and chordal thickening and retraction secondary to rheumatic valve 
disease and type IIIb, with restricted leaflet motion only in systole due to LV remodeling (either 
global or localized) with papillary muscles displacement and chordal tethering. This functional 
classification can be further refined by segmental MV analysis, including scallops and 
commissures assessment which permits precise localization of valve dysfunction. Particularly 
among the degenerative MV diseases (type II MR), this analysis allows the distinction between 
the 2 most common forms: 1. Barlow disease, where the MV shows multi-segment 
redundancy, billowing and thickened tissue, and 2. fibroelastic deficiency, where the  typical 
lesion is a chordal rupture with involvement of one single scallop (3). Characterization of MR 
etiology and MV dysfunction is performed mainly by echocardiography and is crucial to guide 
surgery or transcatheter intervention. Standard 2-dimensional (2D) transthoracic and 
transesophageal echocardiography both permit good morphological analysis of MV and 
subvalvular apparatus with >85% accuracy as compared to surgical inspection (4). However, 2D 
echocardiography showed suboptimal accuracy in the case of complex mitral lesions, such as 
commissural prolapse, bileaflet prolapse or cleft. Furthermore, 2D echocardiography is 
dependent on operator experience and uses geometric assumptions when providing 
quantitative measures for MR severity (vena contracta width and PISA) or mitral valve 
dimensions (annular diameters, leaflet height, etc). The introduction of real-time 3D 
(transesophageal) echocardiography, has significantly improved the diagnostic accuracy, 
showing a >95% agreement with surgical findings and providing detailed description of MV 
dysfunction even in complex lesions, allowing a better communication with the surgeon or 
interventionist (4). Furthermore, when using 3D echocardiography, acquisition and 
interpretation of the images are faster and less operator-dependent. Finally, 3D 
echocardiography enables unlimited image plane orientation for better understanding of the 
complex geometry and spatial relationship between cardiac structures and an optimal 
alignment for geometric assumption-free measurements. 
Transthoracic echocardiography is recommended as the first-line imaging modality for MR 
assessment and provides useful information including valve anatomy, valve hemodynamics 

 
 
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and hemodynamic consequences. When transthoracic echocardiography is of non-diagnostic 
value or when further diagnostic refinement is required, transesophageal echocardiography is 
advocated. Additionally, recent studies have shown the additional value of magnetic 
resonance imaging (MRI) in assessing the MR severity.  
Qualitatively, colour flow imaging is mostly used to assess MR severity. With increasing MR, 
the size and extent of the regurgitant jet into the LA increases. The presence of a large 
eccentric jet adhering, swirling and reaching the posterior LA wall supports significant MR. The 
jet density of the continuous wave (CW) Doppler envelope of the MR jet can be a guide to MR 
severity. A dense MR signal with a full envelope indicates more severe MR than a faint signal. 
In severe MR, the CW envelope may be truncated with a triangular contour and an early peak 
velocity. The presence of flow convergence at a Nyquist limit of 50–60 cm/s should alert to the 
presence of significant MR. A vena contracta width <3 mm indicates mild MR, whereas a width 
≥7 mm defines severe MR. Intermediate values are not accurate for distinguishing moderate 
from mild or severe MR and require the use of another method for verification. Pulsed wave 
Doppler evaluation of the pulmonary venous flow pattern helps grading MR severity. A peak E 
wave velocity >1.5 m/s suggests severe MR in the absence of mitral stenosis. Conversely, a 
dominant A wave virtually excludes severe MR. The pulsed wave Doppler mitral to aortic time 
velocity integral (TVI) ratio is also used as an easily measured index in organic MR. A TVI ratio 
>1.4 strongly suggests severe MR whereas a TVI ratio <1 favours mild MR. 
Quantitatively, the flow convergence method is the most recommended quantitative 
approach. The radius of the proximal isovelocity surface area (PISA) is measured at mid-systole 
using the first aliasing velocity. Regurgitant volume and effective regurgitant orifice area 
(EROA) are obtained using the standard formula. The PISA method is based on the assumption 
of hemispheric symmetry of the velocity distribution proximal to the regurgitant lesion, which 
may not hold for eccentric jets, multiple jets, or complex or elliptical regurgitant orifices. In the 
EACVI recommendations (5), primary MR is considered severe if EROA is ≥40 mm2 and 
regurgitant volume ≥60 mL. In secondary MR, the thresholds of severity, which are of 
prognostic value, are 20 mm2 and 30 mL, respectively. In the 2017, the American Society of 
Echocardiography focused update on the assessment of MR (6), both primary and secondary 
MR are considered severe if EROA is ≥40 mm2, regurgitant volume ≥60 mL and regurgitant 
fraction ≥50%. Assessment of MR using MRI is reasonable to provide additional information on 
aetiology and severity, especially for measurements of regurgitant volume and fraction (7,8), 
whereas the feasibility of MRI for assessing the mechanism of MR and valve repairability are 
not defined yet. Of note, although MRI is more reproducible, each modality has its potential 
errors and limitations and is technically demanding. Finally, the presence of severe MR has 
significant hemodynamic effects, primarily on the LV and LA. When MR is more than mild, it is 
mandatory to provide the LV diameters, volumes and ejection fraction as well as the LA 
volume and the pulmonary arterial systolic pressure in the final echocardiographic report. 
These highlight the unmet clinical need that we still face in clinical practice: low agreement 
across methodologies and observers to grade MR, reliance on 2D echocardiographic data with 
numerous limitations, evaluation of a single frame to extrapolate the quantification of 
regurgitant volume and limited data to compare 3D imaging techniques (echocardiography 
and MRI) to establish the true gold standard for the measurement of the regurgitant volume. 

 
 
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Current technical developments have allowed the 3D reconstruction of the convergence zone 
of the mitral regurgitant jet along the entire systole. This methodology is semiautomated, 
limiting the manipulation of the observer at minimum and therefore improving reproducibility 
of the measurement of regurgitant volume. The 3D-CFQ software (proprietary of Philips 
Ultrasound; see as supplemental material the published white paper and the CE and FDA mark 
approval) has been used in limited cohort of patients and the comparison with 3-dimensional 
vena contracta area of the regurgitant jet as well as with cardiac magnetic resonance-derived 
regurgitant volume has not been extensively evaluated (Figure). 
Figure: Assessment of mitral regurgitation using echocardiography. Panel A sows the parasternal 
biplane views of the mitral regurgitation. Panel B shows the quantification of the regurgitant 
volume using the novel 3D-CFQ software. The arrow points out the 3D reconstructed 
convergence zone. 
 
 
 
2. REFERENCES 
  
 
1. Baumgartner H, Falk V, Bax JJ et al. 2017 ESC/EACTS Guidelines for the management of 
valvular heart disease. Eur Heart J 2017;38:2739-2791. 
2. Carpentier A. Cardiac valve surgery--the "French correction". J Thorac Cardiovasc Surg 
1983;86:323-37. 
3. Carpentier A, Chauvaud S, Fabiani JN et al. Reconstructive surgery of mitral valve 
incompetence: ten-year appraisal. J Thorac Cardiovasc Surg 1980;79:338-48. 
4. Pepi M, Tamborini G, Maltagliati A et al. Head-to-head comparison of two- and three-
dimensional transthoracic and transesophageal echocardiography in the localization of 
mitral valve prolapse. J Am Coll Cardiol 2006;48:2524-30. 
5. Lancellotti P, Tribouilloy C, Hagendorff A et al. Recommendations for the 
echocardiographic assessment of native valvular regurgitation: an executive summary 
from the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc 
Imaging 2013;14:611-44. 
6. Zoghbi WA, Adams D, Bonow RO et al. Recommendations for Noninvasive Evaluation 
of Native Valvular Regurgitation: A Report from the American Society of 
Echocardiography Developed in Collaboration with the Society for Cardiovascular 
Magnetic Resonance. J Am Soc Echocardiogr 2017;30:303-371. 

 
 
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7. Myerson SG, d'Arcy J, Christiansen JP et al. Determination of Clinical Outcome in Mitral 
Regurgitation With Cardiovascular Magnetic Resonance Quantification. Circulation 
2016;133:2287-96. 
8. Uretsky S, Gillam L, Lang R et al. Discordance between echocardiography and MRI in 
the assessment of mitral regurgitation severity: a prospective multicenter trial. J Am 
Coll Cardiol 2015;65:1078-88. 
 
3. HYPOTHESIS 
 
The present study has two hypotheses: 
1.-The 3D-CFQ software provides better agreement with cardiac magnetic resonance to 
quantify mitral regurgitant volume from 3-dimensional transesophageal echocardiography 
as compared to 2-dimensional echocardiographic quantification of mitral regurgitant 
volume.  
2.-In addition, the correlation between 3-dimensional vena contracta area measured on 3-
dimensional echocardiographic data of the regurgitant jet and the regurgitant volume 
quantified with the novel 3D-CFQ software is better than the correlation with 2-
dimensional effective regurgitant orifice area quantified with the proximal isovelocity 
surface area method.    
 
 
4. ENDPOINTS  
 
4.1. Primary and secondary endpoints 
 
The primary objective is to demonstrate that 3D-CFQ software for the quantification of the 
mitral regurgitation is more reproducible and accurate than the conventional assessment of 
mitral regurgitation performed with 2-dimensional echocardiography. 
The secondary objective is to demonstrate the agreement between 3D-CFQ measurement of 
the mitral regurgitant volume and the cardiac magnetic resonance measurement of the 
regurgitant volume is better than the agreement between 2-dimensional echocardiography 
and cardiac magnetic resonance. 
 
5. METHODS 
 
5.1 Type of study 
 
This is a prospective, multicenter observational study. 
 
5.2 Design 
 
This is a prospective, multicenter observational study. Patients with at least moderate 
mitral regurgitation of any etiology who are referred for transesophageal 
echocardiographic evaluation will be included. Patients without contraindications for 

 
 
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cardiac magnetic resonance will undergo this exam to compare the echocardiographic 
data with the cardiac magnetic resonance data as indicated in the study. 
 
5.3 Study population 
 
Inclusion criteria: Patients 18 year-old or older with at least moderate mitral regurgitation 
of any etiology who are referred for transesophageal echocardiographic evaluation and 
provide signed informed consent will be included. Patients without contraindications for 
cardiac magnetic resonance will undergo this exam to compare the echocardiographic 
data with the cardiac magnetic resonance data as indicated in the study. 
 
Exclusion criteria: Patients with contraindications for transesophageal echocardiography or 
cardiac magnetic resonance, patients with mitral valve prosthesis, and patients who do not 
provide informed consent to participate in the study. 
5.4 Variables  
 
5.4.1 
Outcome, exposure or effect variables 
The study will analyse multiple variables, including demographic characteristics such as 
age and sex. Clinical parameters will encompass cardiovascular risk factors, presenting 
symptoms, and relevant laboratory data.  
Echocardiographic data: conventional data to define etiology of the mitral 
regurgitation and grade of mitral regurgitation. Quantitative data of mitral 
regurgitation including: vena contracta area, effective regurgitant orifice, regurgitant 
volume. 
Cardiac magnetic resonance: conventional data of cardiac chamber dimensions, mitral 
regurgitant volume with phase contrast sequences. 
 
5.5 Study evaluations: 
 
Transthoracic and transesophageal echocardiography and cardiac magnetic resonance, all 
clinically indicated for the management of the patients. Patients will not be exposed to 
additional examinations that are not clinically indicated. 
 
 
5.6 Sample size 
 
The ideal number of patients for an international, multicenter study comparing three-
dimensional transesophageal echocardiography and cardiac magnetic resonance imaging 
for quantifying mitral regurgitation should be at least 150 patients. This sample size is 
justified by the need to ensure adequate statistical power for subgroup analyses (e.g., 
primary vs. secondary mitral regurgitation, varying degrees of severity, and jet 
morphology), to account for inter-center variability, and to provide robust estimates of 
agreement and diagnostic accuracy. 
 

 
 
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Previous multicenter studies comparing echocardiography and CMR for mitral 
regurgitation have included 103 patients, while meta-analyses have aggregated data from 
over 1,000 patients across multiple studies, but these have not focused exclusively on 
head-to-head three-dimensional transesophageal echocardiography vs cardiac magnetic 
resonance comparisons. Single-center studies with direct 3D TEE-CMR comparison have 
been limited to 30 patients. Given the heterogeneity of mitral regurgitation and the need 
for generalizability across diverse populations and imaging platforms, a sample size in the 
150-200 range is consistent with contemporary multicenter imaging studies and would 
allow for meaningful statistical analysis and external validity. This approach aligns with the 
consensus in the imaging literature that larger, multicenter studies are needed to validate 
and refine quantitative imaging techniques for mitral regurgitation.  
 
5.7 Statistical analysis 
 
Categorical variables are presented as frequencies and percentages, and continuous 
variables are reported as mean ± standard deviation or median with interquartile range 
(IQR) according to the distribution of the variable. The Student T-test was used for 
comparison of continuous variables, and the Chi-square test was used to compared 
categorical variables. Correlations will be assessed with the Pearson test. Reproducibility 
data will be assessed with the intraclass correlation coefficients and the Bland-Altman 
plots. A p-value of <0.05 was considered statistically significant for all analyses. All 
statistical tests were two-sided. 
 
 
5.8 Study limitations  
 
The limitations of the study include the possibility of selection bias (only patients with at least 
moderate mitral regurgitation) and the change in loading conditions between the 
transesophageal echocardiography and the cardiac magnetic resonance. 
 
6. SOURCES FOR OBTAINING AND MANAGING DATA 
 
6.1 Source of data 
 
The data will be collected from medical records and PACs. 
 
6.2 Data management and quality control 
 
Data will be systematically recorded and stored pseudoanonymised in a secured database. 
Procedures will be implemented to identify and address missing or erroneous data, 
including cross-checking and validation against source records.  
Imaging (echocardiographic and cardiac magnetic resonance) data will be uploaded to a 
research platform on the IGTP campus, called ARIADNA (Archive of Imaging Data for the 

 
 
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Development of New Applications). This IT infrastructure allows you to manage and share 
medical images securely with the project researchers, without violating the confidentiality 
of the data. The procedure, before transferring the images to the platform, includes a 
pseudo-anonymization process, this allows the images uploaded to the platform to not 
contain any personal data, but the process of eliminating the name and data is reversible if 
necessary, for clinical or research reasons. This is possible because the decoding is 
recorded on an internal HGTP computer, protected by a password. The pseudonymization 
of the collected data in the database is performed by a third person with technical and 
functional independence from the research team and access to SAP.  Once the images are 
pseudo-anonymized and available in ARIADNA, a comparative analysis of the images will 
be carried out, which must guarantee the coherence of the information obtained from 
both acquisition techniques. 
 
7. ETHICAL AND LEGAL ASPECTS 
 
Commitment to submitting the study for evaluation by an accredited Research Ethics 
Committee (CEIm). 
 
Commitment to complying with the fundamental ethical principles outlined in the 
Declaration of Helsinki (Helsinki, October 2024) and with the specific regulations applicable 
to the type of study: 
 
- 
Research involving the analysis and storage of biological material: Law 14/2007 on 
Biomedical Research and Royal Decree 1716/2011 on the regulation of Biobanks. 
- 
Observational studies with medicinal products: Royal Decree 957/2020, of November 3, 
regulating observational studies with medicinal products for human use. 
 
 
 
7.1 Benefit-risk assessment for research subjects 
 
If the study demonstrates the hypotheses, the benefit for the patients is obvious since we 
will be validating a novel method that is more accurate and reproducible to quantify mitral 
regurgitation, improving the decision making of the patients. 
 
7.2 Information to subjects and informed consent 
Patients will be informed about the clinically indicated examinations and the 
postprocessing of the data for research purposes, without impacting on the decision 
making of the patients. Patients will be asked to sign the informed consent for the use of 
the acquired data for research purposes. 
 
7.3  Confidentiality and data protection 
 

 
 
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All patient data will be pseudoanonymised and handled in compliance with national and 
EU data protection laws, including the General Data Protection Regulation (GDPR) and 
Spanish Organic Law 3/2018. Data will be securely stored, with access restricted to 
authorized researchers only. 
 
7.4 Interference with prescribing and dispensing habits 
 
This is a prospective observational study and the results will not impact on the clinical 
management of the patients. 
 
 
7. MANAGEMENT AND COMMUNICATION OF ADVERSE REACTIONS 
 
The examinations that will be performed are clinically indicated and the risk of 
complications is minimal. However, any significant findings regarding patient safety or 
potential complications identified in the data analysis will be communicated to the 
relevant clinical authorities. 
 
 
8. OBTAINING AND MANAGING BIOLOGICAL SAMPLES 
 
If imaging data is considered a biological sample, the data will be stored in PACS 
and additionally for the multicenter design of the study, only the 
echocardiographic and cardiac magnetic resonance data will be uploaded to a 
research platform on the IGTP campus, called ARIADNA (Archive of Imaging Data for the 
Development of New Applications). This IT infrastructure allows you to manage and share 
medical images securely with the project researchers, without violating the confidentiality 
of the data. The procedure, before transferring the images to the platform, includes a 
pseudo-anonymization process, this allows the images uploaded to the platform to not 
contain any personal data, but the process of eliminating the name and data is reversible if 
necessary, for clinical or research reasons. This is possible because the decoding is 
recorded on an internal HGTP computer, protected by a password. This process will be 
done internally at the HGTP.  Once the images are pseudo-anonymized and available in 
ARIADNA, a comparative analysis of the images will be carried out, which must guarantee 
the coherence of the information obtained from both acquisition techniques. 
 
9. PLANS FOR DISSEMINATION AND COMMUNICATION OF RESULTS 
 
The study findings will be presented at scientific conferences and submitted for publication 
in peer-reviewed medical journals. 
 

 
 
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10. SOURCE OF FUNDING 
Philips will support providing the ultrasound system equipped with the software and the 
offline software for analysis of the data. 
 
 
11. WORK PLAN FOR CARRYING OUT THE STUDY 
1 
Data Collection: Prospective acquisition of echocardiographic and cardiac magnetic 
resonance data  
2 
Data Analysis: Statistical processing and evaluation  
3 
Manuscript Preparation and Submission: Final study report preparation for 
publication in peer-reviewed medical journals