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?

NCT ID: NCT04002648

Last Updated: 2020-08-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

208 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-01

Study Completion Date

2016-12-01

Brief Summary

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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

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Conditions

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Barlow's Disease Prolapse; Mitral

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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MT-Right

Right minithoracotomy

Intervention Type PROCEDURE

Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space

Sternotomy

Sternotomy

Intervention Type PROCEDURE

Longitudinal resection of the sternum

Interventions

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Right minithoracotomy

Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space

Intervention Type PROCEDURE

Sternotomy

Longitudinal resection of the sternum

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Age inferior to 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Michele De Bonis

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 22922698 (View on PubMed)

Other Identifiers

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MICETE-BBL

Identifier Type: -

Identifier Source: org_study_id

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