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Additive Prognostic Value of PALS Compared to Bernard's Staging in Patients Undergoing MV Surgery

NCT07151495 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-09-03

No results posted yet for this study

Summary

Mitral valve prolapse is the most common cause of mitral regurgitation requiring surgery in developed countries. While cardiac surgery is recommended for symptomatic patients, in accordance with the ESC guidelines on valvular heart disease, indications for intervention in asymptomatic patients are mainly based on two-dimensional echocardiographic criteria: the presence of left ventricular systolic dysfunction or dilatation (end-systolic diameter ≥ 40 mm and/or ejection fraction ≤ 60%); or, in patients with preserved left ventricular systolic function, the occurrence of atrial fibrillation secondary to valvular disease or pulmonary hypertension (systolic pulmonary artery pressure \> 50 mmHg); finally, significant left atrial dilatation (indexed left atrial volume ≥ 60 ml/m² or diameter ≥ 55 mm) also represents an indication. Mitral valve repair is preferred over valve replacement with a prosthesis, as it is associated with lower intraoperative mortality, better long-term survival, and fewer valve-related complications. However, the cut-off values derived from conventional echocardiography and used as indicators for surgical intervention may reflect an already severe and irreversible structural and functional cardiac alteration. Moreover, they do not consider more advanced imaging techniques such as speckle tracking echocardiography, which is now widely used in clinical practice and allows for a quantitative assessment of myocardial function through the analysis of myocardial fiber shortening in the cardiac walls. Several studies have shown that preoperative peak left atrial longitudinal strain (PALS) has prognostic value in predicting postoperative clinical outcomes in patients undergoing surgery for primary mitral regurgitation, as well as in predicting left atrial reverse remodeling; this prognostic relevance has also been observed in asymptomatic patients and in cases of less than severe mitral regurgitation. Furthermore, Bernard et al. demonstrated the prognostic value of a staging system for extra-valvular cardiac damage, assessed using two-dimensional echocardiographic data, in asymptomatic patients with moderate or severe mitral regurgitation.

Conditions

  • Mitral Regurgitation

Interventions

DIAGNOSTIC_TEST

Speckle tracking and 2D echocardiography

The study will involve only the collection of data obtained from routine clinical procedures and a telephone follow-up. Preoperative echocardiographic data and pre-operative left atrial speckle tracking data will be retrieved

Sponsors & Collaborators

  • University of Siena

    collaborator OTHER

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Annalisa Pasquini, MD, PhD · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2025-12-15
Completion
2026-01-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07151495 on ClinicalTrials.gov