Clinical trial · Observational
Novel 3-dimensional Echocardiographic Quantification of Mitral Regurgitant Volume
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Moderate or Severe Mitral Regurgitation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| analysis of the performance of an artificial intelligenced based software for analysis of 3D tranesophageal echocardiography data | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Consecutive patients with at least moderate mitral regurgitaiton
- description
- 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.
- interventionNames
- Device: analysis of the performance of an artificial intelligenced based software for analysis of 3D tranesophageal echocardiography data
Primary outcomes (1)
- measure
- Accuracy of 3DCFQ to quantify mitral regurgitation
- timeFrame
- 2 years
- description
- 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
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with at least moderate mitral regurgitation of any etiology * Patients with good transesophageal echocardiography image quality Exclusion Criteria: * Patients with prior transcatheter or surgical mitral valve intervention * Patients with contraindications for transesophageal echocardiography or cardiac magnetic resonance
References
Publications (2)
- BACKGROUNDLancellotti 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
- BACKGROUNDPraz 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