Status:
NOT_YET_RECRUITING
Additive Prognostic Value of PALS Compared to Bernard's Staging in Patients Undergoing MV Surgery
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborating Sponsors:
University of Siena
Conditions:
Mitral Regurgitation
Eligibility:
All Genders
18+ years
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 E...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 15 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07151495
Start Date
September 15 2025
End Date
January 15 2026
Last Update
September 3 2025
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