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NCT07151495

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

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

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.

Official title: The Additive Prognostic Value of Speckle Tracking Echocardiography Compared to Bernard's Staging in Patients Undergoing Mitral Valve Surgery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2025-09-15

Completion Date

2026-01-15

Last Updated

2025-09-03

Healthy Volunteers

No

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