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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?

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ClinicalTrials.gov Identifier: NCT04002648
Recruitment Status : Completed
First Posted : June 28, 2019
Results First Posted : February 19, 2020
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
Michele De Bonis, Ospedale San Raffaele

Brief Summary:
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.

Condition or disease Intervention/treatment
Barlow's Disease Prolapse; Mitral Procedure: Right minithoracotomy Procedure: Sternotomy

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Study Type : Observational
Actual Enrollment : 208 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: 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?
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2016

Group/Cohort Intervention/treatment
MT-Right Procedure: Right minithoracotomy
Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space

Sternotomy Procedure: Sternotomy
Longitudinal resection of the sternum




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with severe MR due to the prolapse of both leaflets in the context of Barlow's disease submitted to EE repair via a video-assisted right minithoracotomy (minithoracotomy group) and patients with Barlow's disease treated with surgical mitral repair with the EE technique through a conventional median sternotomy (sternotomy group).

The diagnosis of Barlow's disease was made during a preoperative transoesophageal echocardiographic (TEE) examination and confirmed by the surgeon's direct assessment of the valve. All patients had excessive leaflet tissue, annular dilatation and bileaflet prolapse. Cases with a forme fruste of Barlow's disease were excluded.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Age inferior to 18 years

Publications:
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Responsible Party: Michele De Bonis, Principal Investigator, Ospedale San Raffaele
ClinicalTrials.gov Identifier: NCT04002648    
Other Study ID Numbers: MICETE-BBL
First Posted: June 28, 2019    Key Record Dates
Results First Posted: February 19, 2020
Last Update Posted: August 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Prolapse
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases