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

This study has been completed.
Sponsor:
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01246141
First received: November 20, 2010
Last updated: November 22, 2010
Last verified: January 1998
History of Changes
  Purpose

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
Tricuspid Valve Regurgitation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: The Institute of Cardiovascular Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Xijing Hospital:

Enrollment: 68
Study Start Date: January 1998
Study Completion Date: April 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 67 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients with aortic valve and mitral valve diseases and functional tricuspid valve regurgitation underwent surgical operations from Nov., 1998 to Dec., 2009 in our institute.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246141

Locations
China, Shaanxi
Zhang Jinzhou
Xi`an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Investigators
Principal Investigator: zhang jinzhou, MD Xijing Hospital
  More Information

No publications provided

Responsible Party: zhang jinzhou, the departement of cardiovascular surgery, xijing hospital
ClinicalTrials.gov Identifier: NCT01246141     History of Changes
Other Study ID Numbers: 20101012
Study First Received: November 20, 2010
Last Updated: November 22, 2010
Health Authority: China: Ministry of Health

Keywords provided by Xijing Hospital:
tricuspid valve regurgitation
replacement
repair
outcomes

Additional relevant MeSH terms:
Heart Valve Diseases
Tricuspid Valve Insufficiency
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013