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?

Completed

• Conditions: Prolapse; Mitral; Barlow's Disease
• Interventions: Procedure: Right minithoracotomy; Procedure: Sternotomy

• Registration Number: NCT04002648
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-01
• Primary Completion: 2016-12-01
• Study Completion: 2016-12-01
• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-06-27
• Study First Posted: 2019-06-28
• Results First Submitted: 2020-02-06
• Results First Submitted QC: 2020-02-06
• Results First Posted: 2020-02-19
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

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

Exclusion Criteria

Age inferior to 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MT-Right	Right minithoracotomy	-
Sternotomy	Sternotomy	-

Primary Outcome Measures

Name	Time	Method
Cardiac Death	12 years	The cumulative incidence function (CIF) of cardiac death at 12 years, with noncardiac death as a competing risk
Severe MR	12 years	The cumulative incidence function (CIF) of recurrent mitral regurgitation (MR) \>_ 3+, with death as the competing risk