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The Comparison of Tricuspid Replacement and Repair in Patients With Combined Heart Valve Disease

Sponsor
Xijing Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01246141
Collaborator
(none)
68
Enrollment
1
Location
147
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Functional tricuspid regurgitation is common in patients with heart valve disease, replacement and repair both can correct this anomaly. However, there is no data to address which one can bring more benefits to these patients with combined heart valve disease. The investigators retrospectively review patients with two or more heart valve disease and functional tricuspid regurgitation, and assess its long term outcomes.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    we reviewed patients who admitted to our hospital due to combined heart valve disease, and underwent tricuspid valve replacement or repair from January,1998 to december,2009. we made a comparison between these two groups, in term of early results after operation and long term results.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    68 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    The Institute of Cardiovascular Surgery
    Study Start Date :
    Jan 1, 1998
    Actual Primary Completion Date :
    Dec 1, 2009
    Actual Study Completion Date :
    Apr 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Repair group

    patients in repair group underwent tricuspid repair for functional tricuspid regurgitation.
    replacement group

    In this group, patients underwent tricuspid valve replacement for functional tricuspid regurgitation.

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      21 Years to 67 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Significant disorders in aortic and mitral valves

      • Moderate ～ severe tricuspid regurgitation

      • Underwent tricuspid repair or replacement operation

      Exclusion Criteria:

      • Isolate tricuspid valve lesion

      • Mild tricuspid valve regurgitation

      • Tricuspid valve regurgitation was left without surgical treatment

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Zhang Jinzhou Xi'an Shaanxi China 710032

      Sponsors and Collaborators

      • Xijing Hospital

      Investigators

      • Principal Investigator: zhang jinzhou, MD, Xijing Hospital

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01246141
      Other Study ID Numbers:
      • 20101012
      First Posted:
      Nov 23, 2010
      Last Update Posted:
      Nov 23, 2010
      Last Verified:
      Jan 1, 1998
      Keywords provided by , ,
      tricuspid valve regurgitation
      replacement
      repair
      outcomes
      Additional relevant MeSH terms:
      Tricuspid Valve Insufficiency

      Study Results

      No Results Posted as of Nov 23, 2010