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

NCT ID: NCT05836532

Last Updated: 2023-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-05

Study Completion Date

2019-10-15

Brief Summary

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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).

Detailed Description

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Conditions

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Degenerative Mitral Valve Disease Mitral Regurgitation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Central edge-to-edge

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

Intervention Type PROCEDURE

Eligibility Criteria

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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...)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michele De Bonis

OTHER

Sponsor Role lead

Responsible Party

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Michele De Bonis

Chief od Cardiac Surgery of Advanced and Research Therapies

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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IRCCS Ospedale San Raffaele - Cardiac Surgery Department

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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LORD-P2_DMR

Identifier Type: -

Identifier Source: org_study_id

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