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NCT05836532 Clinical Trial

Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation

Mitral Regurgitation Clinical Trial

Official title:
Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05836532
Other study ID # LORD-P2_DMR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 5, 2019
Est. completion date October 15, 2019

Study information
Verified date April 2023
Source Ospedale San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Mitral regurgitation is a pathology affecting the left atrioventricular valve that causes a volumetric and pressure overload in the left chambers due to the loss of unidirectionality normally guaranteed by the cardiac valve system. The gold standard for severe mitral regurgitation is currently mitral valve plastic surgery. Edge to edge, on the other hand, allows shorter CEC and aortic clamping times and does not require significant surgical experience in the field of mitral valve repair, therefore edge to edge could be an excellent strategy in patients suffering from mitral regurgitation caused by P2 prolapse when quadrangular resection cannot be performed. The main objective of the present study is to examine the medium to long-term outcomes (in terms of survival and plastic outcomes) of patients undergoing central edge-to-edge to treat posterior flap pathology (P2).

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date October 15, 2019
Est. primary completion date October 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Mitral regurgitation with degenerative etiology - Mitral pathology exclusively dependent on P2 - Surgical creation of a double mitral valve orifice with or without a ring as the only mitral valve repair technique. Exclusion Criteria: - Other mitral regurgitation etiologies (eg. functional, radiation-induced, rheumatic...)

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Central edge-to-edge
Suture of free margins of the mitral leaflets in central position to restore coaptation

Locations
Country Name City State
Italy IRCCS Ospedale San Raffaele - Cardiac Surgery Department Milan

Sponsors (1)
Lead Sponsor Collaborator
Michele De Bonis

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary MR 2+ or more recurrency through study completion, a minimum of 2 years
Secondary Reintervention through study completion, a minimum of 2 years
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