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?
1 other identifier
observational
208
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 27, 2019
CompletedFirst Posted
Study publicly available on registry
June 28, 2019
CompletedResults Posted
Study results publicly available
February 19, 2020
CompletedAugust 7, 2020
July 1, 2020
Same day
June 27, 2019
February 6, 2020
July 21, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Cardiac Death
The cumulative incidence function (CIF) of cardiac death at 12 years, with noncardiac death as a competing risk
12 years
Severe MR
The cumulative incidence function (CIF) of recurrent mitral regurgitation (MR) \>\_ 3+, with death as the competing risk
12 years
Study Arms (2)
MT-Right
Sternotomy
Interventions
Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space
Eligibility Criteria
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.
You may qualify if:
- Patients treated for bileaflet prolapse in Barlow's Disease between 1997 and 2011
You may not qualify if:
- Age inferior to 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; ESC Committee for Practice Guidelines (CPG); Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012 Oct;42(4):S1-44. doi: 10.1093/ejcts/ezs455. Epub 2012 Aug 25. No abstract available.
PMID: 22922698BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Limitations due to retrospective design.
Results Point of Contact
- Title
- Prof. Michele De Bonis
- Organization
- IRCCSSRaffaele
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 27, 2019
First Posted
June 28, 2019
Study Start
December 1, 2016
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
August 7, 2020
Results First Posted
February 19, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share