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Completed

NCT Number: NCT04002648

Minimally Invasive or Conventional Edge-To-Edge Repair for Severe Mitral Regurgitation Due to Bileaflet Prolapse in Barlow's Disease: Does the Surgical Approach Have an Impact on the Long-term Results?

The study evaluates the long-term results of patients affected by bileaflet prolapse in Barlow's Disease, treated with edge-to-edge technique between 1997 and 2011.

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Key information

Conditions

Barlow's Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Heart Valve Prolapse Mitral Valve Prolapse Prolapse; Mitral

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients treated for bileaflet prolapse in Barlow's Disease between 1997 and 2011

Exclusion criteria

Age inferior to 18 years

Treatment and study plan

Right minithoracotomy

Procedure

Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space

Sternotomy

Procedure

Longitudinal resection of the sternum

Primary outcomes

  1. Cardiac Death

    Time frame: 12 years

    The cumulative incidence function (CIF) of cardiac death at 12 years, with noncardiac death as a competing risk

  2. Severe MR

    Time frame: 12 years

    The cumulative incidence function (CIF) of recurrent mitral regurgitation (MR) >_ 3+, with death as the competing risk

Sponsors and collaborators

Lead sponsor

Ospedale San Raffaele

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 28, 2019
Registry last updated
Aug 7, 2020

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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