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

NCT07151495 | Not Yet Recruiting

• 1 other identifier: 7837
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• All cause or cardiovascular mortality

  To determine the additive prognostic value for the primary outcome (all cause or cardiovascular mortality) of left atrial speckle-tracking echocardiography (PALS) over Bernard's staging

  3 months

Secondary Outcomes (1)

• Composite endpoint: all cause or cardiovascular mortality, new onset of atrial fibrillation, hospitalization for cardiovascular cause (heart failure, acute coronary syndrome)

  3 months

Interventions

Speckle tracking and 2D echocardiography DIAGNOSTIC_TEST

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

Eligibility Criteria

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

Study Population

Patients with severe primary mitral regurgitation treated with cardiac surgery

You may qualify if:

• Patients with severe primary mitral regurgitation treated with cardiac surgery
• Age \> 18 years
• Signed informed consent form/Substitute declaration in place of the signed informed consent form in the case of deceased patients

You may not qualify if:

• Known coronary artery disease
• Infective endocarditis
• Functional mitral regurgitation
• Presence of additional left-sided valvular heart disease greater than mild
• History of prior cardiac surgery
• History of rheumatic valvular disease
• Pregnancy
• Absence of a signed informed consent form/Absence of the signed substitute declaration in the case of deceased patients

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• University of Siena: collaborator

MeSH Terms

Conditions

Mitral Valve Insufficiency

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Annalisa Pasquini, MD, PhD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annalisa Pasquini, MD, PhD

CONTACT

+390630155701; annalisa.pasquini@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: September 3, 2025
• Study Start: September 15, 2025
• Primary Completion: December 15, 2025
• Study Completion: January 15, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share