N/A
N=208
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?
Barlow's Disease · Prolapse; Mitral
Bottom Line
View on ClinicalTrials.gov: NCT04002648 ↗Enrolled (actual)
208
Serious AEs
10.2%
Results posted
Feb 2020
Primary outcome: Primary: Cardiac Death — 3.9; 3.8 percentage of participants with event
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Right minithoracotomy (Procedure); Sternotomy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ospedale San Raffaele
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiac Death |
3.9; 3.8 | — |
| PRIMARY Severe MR |
5.8; 11.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
Patients treated for bileaflet prolapse in Barlow's Disease between 1997 and 2011
Exclusion Criteria
Age inferior to 18 years
Data sourced from ClinicalTrials.gov (NCT04002648). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.