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NCT01246141 Clinical Trial

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

Tricuspid Valve Regurgitation Clinical Trial

Official title:
The Institute of Cardiovascular Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01246141
Other study ID # 20101012
Secondary ID
Status Completed
Phase N/A
First received November 20, 2010
Last updated November 22, 2010
Start date January 1998
Est. completion date April 2010

Study information
Verified date January 1998
Source Xijing Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date April 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 67 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
China Zhang Jinzhou Xi`an Shaanxi

Sponsors (1)
Lead Sponsor Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

See also
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Completed NCT02787408 - The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System N/A
Completed NCT02981953 - TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System N/A
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Recruiting NCT05194423 - THE TRAVEL II TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve Via Jugular Vein N/A
Recruiting NCT05767645 - Mistral Percutaneous Tricuspid Valve Durable Repair Pivotal Study N/A
Withdrawn NCT03928639 - Structural Heart and Valve Network PROSPECTIVE Registry
Not yet recruiting NCT05577078 - TriBEL Registry: National Belgian Registry of Percutaneous Tricuspid Valve Repair Using a Transcatheter Edge-to-edge Repair Technique
Recruiting NCT05760989 - TRISCEND JAPAN Study N/A
Completed NCT02471807 - Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System N/A
Completed NCT04071652 - MATTERS Study - Mistral Percutaneous Tricuspid Valve Repair FIM Study N/A
Active, not recruiting NCT04483089 - An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device (bRIGHT)
Not yet recruiting NCT05936125 - Short Term Outcomes Of Tricuspid Valve Annuloplasty Using A Flexible Band N/A
Recruiting NCT04482062 - TRISCEND II Pivotal Trial N/A
Completed NCT04073979 - MATTERS II - Mistral Percutaneous Tricuspid Valve Repair FIM Study N/A