Long-term Outcome After Isolated Tricuspid Valve Repair

Tricuspid Valve Insufficiency Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01537458
• Other study ID #: Is_TVR_1
• Status: Completed
• Start date: March 19, 2012
• Est. completion date: March 1, 2013

Study information

• Verified date: February 2012
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Tricuspid valve insufficiency (TI) is often noted on echocardiography. Although severe TI is known to cause significant morbidity and mortality, no good guidelines are available to guide intervention. Literature is mostly confined to tricuspid valve repair concomitant with mitral valve repair. Treatment options for isolated repair have not been investigated thoroughly.

The investigators want to evaluate retrospectively the outcome of isolated tricuspid valve repair, performed in our center. By doing this, the investigators want to evaluate predictors of outcome after repair.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 1, 2013
• Est. primary completion date: June 30, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• tricuspid valve insufficiency

Exclusion Criteria:

• younger than 18 years

• associated valvular surgery

Related Conditions & MeSH terms

• Tricuspid Valve Insufficiency

Intervention

Procedure:
• follow-up of isolated tricuspid valve repair
follow-up of patients that underwent TV repair in the past.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven	Vlaams-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	Agency for Science, Technology and Research

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality		10 year
Primary	Redo surgery		10 year
Secondary	functional capacity assessed by CPET		10 year
Secondary	Atrial fibrillation		10 year
Secondary	Hospitalisation	hospitalisation for cardiovascular reasons	10 year
Secondary	Functional capacity assessed by NYHA functional class		10 years