Novel 3-dimensional Echocardiographic Quantification of Mitral Regurgitant Volume

NCT07528781 | Recruiting FDA Device

• 1 other identifier: 3D-CFQ-MR
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is demonstrate that a novel artificial intelligence based software for the quantification of the mitral regurgitation on 3-dimensional transesophageal echocardiography (3D CFQ) is more reproducible and accurate than the conventional assessment of mitral regurgitation performed with 2-dimensional echocardiography. The main question aims to answer 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. If this is demonstrated, we would like to test the accuracy of this tool to be applied in acute settings such as transcatheter interventions to decide the therapy to follow. Participants will undergo clinically indicated transesophageal echocardiography to characterize the mechanism and severity of mitral regurgitation and to cardiac magnetic resonance to be used as reference stadard to define the mitral regurgitation severity.

Conditions

Moderate or Severe Mitral Regurgitation

Keywords

mitral regurgitation; mitral valve surgery; transcatheter intervention

Outcome Measures

Primary Outcomes (1)

• Accuracy of 3DCFQ to quantify mitral regurgitation

  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 years

Secondary Outcomes (1)

• Validation of 3DCFQ to quantify mitral regurgitation

  2 years

Study Arms (1)

Consecutive patients with at least moderate mitral regurgitaiton

Patients with at least moderate mitral regurgitation of any etiology who are referred for transesophageal echocardiographic evaluation 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.

Device: analysis of the performance of an artificial intelligenced based software for analysis of 3D tranesophageal echocardiography data

Interventions

analysis of the performance of an artificial intelligenced based software for analysis of 3D tranesophageal echocardiography data DEVICE

The analysis of mitral regurgitation in current practice is based on multiparametric approach of several 2-dimensional Doppler echocardiographic parameters and quantification of mitral regurgitant volume and effective regurgitant orifice area measured with the proxymal isovelocity surface area. This novel algorithm based on artificial intelligence based software may change clinical practice if demonstrates that provides more accurate estimation of the severity of mitral regurgitation.

Consecutive patients with at least moderate mitral regurgitaiton

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years old or older with at least moderate mitral regurgitation of any etiology (primary or secondary) who are referred for transesophageal echocardiographic evaluation will be included. During the same day or within 5 days of transesophageal echocardiography, patients with undergo cardiac magnetic resonance. Patients with multiple regurgitant jets will not be excluded. In addition, patients with concomitant mitral stenosis, or other valvular heart disease will not be excluded. Patients with prior mitral valve intervention or bad image quality for analysis of 3D color flow or cardiac magnetic resonance will be excluded. Patients with contraindications for cardiac magnetic resonance will be excluded.

You may qualify if:

• Patients with at least moderate mitral regurgitation of any etiology
• Patients with good transesophageal echocardiography image quality

You may not qualify if:

• Patients with prior transcatheter or surgical mitral valve intervention
• Patients with contraindications for transesophageal echocardiography or cardiac magnetic resonance

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead

Study Sites (1)

Hospital University Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

Related Publications (2)

• Lancellotti P, Tribouilloy C, Hagendorff A, Popescu BA, Edvardsen T, Pierard LA, Badano L, Zamorano JL; Scientific Document Committee of the European Association of Cardiovascular Imaging. 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 Jul;14(7):611-44. doi: 10.1093/ehjci/jet105. Epub 2013 Jun 3.

  PMID: 23733442 BACKGROUND

• Praz F, Borger MA, Lanz J, Marin-Cuartas M, Abreu A, Adamo M, Ajmone Marsan N, Barili F, Bonaros N, Cosyns B, De Paulis R, Gamra H, Jahangiri M, Jeppsson A, Klautz RJM, Mores B, Perez-David E, Poss J, Prendergast BD, Rocca B, Rossello X, Suzuki M, Thiele H, Tribouilloy CM, Wojakowski W; ESC/EACTS Scientific Document Group. 2025 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2025 Nov 21;46(44):4635-4736. doi: 10.1093/eurheartj/ehaf194. No abstract available.

  PMID: 40878295 BACKGROUND

MeSH Terms

Conditions

Lymphoma, Follicular; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Carlo F Guarino, MD

  Hospital University Germans Trias i Pujol

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Delgado, Head of Cardiovascular Imaging department, MD, PhD

CONTACT

+34 93 497 89 15; cardiologia.germanstrias@gencat.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 14, 2026
• Study Start: March 17, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 08/03/2026 to 01/04/2028
• Access Criteria: Invesitgators that will join the project and will have ethical committee approval of the study and dta share agreement

Locations

ES (1)