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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05836532
Enrollment
110
Registered
2023-05-01
Start date
2019-10-05
Completion date
2019-10-15
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Mitral Valve Disease, Mitral Regurgitation

Brief 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).

Interventions

PROCEDURECentral edge-to-edge

Suture of free margins of the mitral leaflets in central position to restore coaptation

Sponsors

Michele De Bonis
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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...)

Design outcomes

Primary

MeasureTime frame
MR 2+ or more recurrencythrough study completion, a minimum of 2 years

Secondary

MeasureTime frame
Reinterventionthrough study completion, a minimum of 2 years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026