NCT01246141

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 1998

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 1998

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2010

Completed
Last Updated

November 23, 2010

Status Verified

January 1, 1998

Enrollment Period

11.9 years

First QC Date

November 20, 2010

Last Update Submit

November 22, 2010

Conditions

Tricuspid Valve Regurgitation

Keywords

tricuspid valve regurgitationreplacementrepairoutcomes

Study Arms (2)

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.

Eligibility Criteria

Age21 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Significant disorders in aortic and mitral valves
  • Moderate ～ severe tricuspid regurgitation
  • Underwent tricuspid repair or replacement operation

You may not qualify if:

  • Isolate tricuspid valve lesion
  • Mild tricuspid valve regurgitation
  • Tricuspid valve regurgitation was left without surgical treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhang Jinzhou

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • zhang jinzhou, MD

    Xijing Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 20, 2010

First Posted

November 23, 2010

Study Start

January 1, 1998

Primary Completion

December 1, 2009

Study Completion

April 1, 2010

Last Updated

November 23, 2010

Record last verified: 1998-01

Locations

CN(1)