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 Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04002648
• Other study ID #: MICETE-BBL
• Status: Completed
• Start date: December 1, 2016
• Est. completion date: December 1, 2016

Study information

• Verified date: July 2020
• Source: Ospedale San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Age inferior to 18 years

Related Conditions & MeSH terms

• Barlow's Disease
• Mitral Valve Insufficiency
• Prolapse
• Prolapse; Mitral

Intervention

Procedure:
• Right minithoracotomy
Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space
• Sternotomy
Longitudinal resection of the sternum

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale San Raffaele

References & Publications (1)

Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Barón-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schäfers 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Death	The cumulative incidence function (CIF) of cardiac death at 12 years, with noncardiac death as a competing risk	12 years
Primary	Severe MR	The cumulative incidence function (CIF) of recurrent mitral regurgitation (MR) >_ 3+, with death as the competing risk	12 years