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OpenTrials
Completed

NCT Number: NCT05839782

Long Term Results in Redo Mitral Valve Surgery After Mitral Valve Repair

The current gold standard for severe mitral regurgitation is mitral valve plasty (PLM). The surgery allows the repair of the mitral valve, therefore without the need for mitral valve replacement (SVM), which involves the implantation of a biological prosthesis or a mechanical prosthesis.

However, PLM has a rate of failure, between 1-4% per year in degenerative mitral pathologies. As a result, patients with PLM failure and severe residual regurgitation are increasingly presenting in recent years.

Generally these patients are re-operated to replace the mitral valve. Our aim is to investigate the differences in re-operation involving mitral valve replacement or re-repair in patients who underwent mitral valve re-operation (re-repair or replacement) in our center between 2003 and 2017.

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Key information

Conditions

Degenerative Mitral Valve Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele - Cardiac Surgery Department

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients
  • failure of previous mitral valve repair which needed a new surgical treatment
  • group Re-PLM: patients reoperated with a new mitral valve repair
  • group Re-SVM: patients reoperated with a mitral valve replacement

Exclusion criteria

  • urgent/emergent procedures

Treatment and study plan

Mitral valve repair (PLM)

Procedure

A mitral valve plasty is performed to treat mitral regurgitation

Mitral valve replacement

Procedure

A mitral valve replacement with a prosthesis is performed to treat mitral regurgitation

Primary outcomes

  1. Survival after reintervention

    Time frame: through study completion, a minimum of 2 years

    Time of survival after reintervention for failed mitral valve repair

Secondary outcomes

  1. Risk factors for reintervention

    Time frame: through study completion, a minimum of 2 years

    Identification of predictors of reintervention after mitral valve repair

Sponsors and collaborators

Lead sponsor

Michele De Bonis

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 3, 2023
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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