Long-term Outcome After Isolated Tricuspid Valve Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Agency for Science, Technology and Research
Information provided by (Responsible Party):
Pieter De Meester, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01537458
First received: February 13, 2012
Last updated: February 22, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Tricuspid Valve Insufficiency
Procedure: follow-up of isolated tricuspid valve repair

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • mortality [ Time Frame: 10 year ] [ Designated as safety issue: No ]
  • Redo surgery [ Time Frame: 10 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • functional capacity assessed by CPET [ Time Frame: 10 year ] [ Designated as safety issue: No ]
  • Atrial fibrillation [ Time Frame: 10 year ] [ Designated as safety issue: No ]
  • Hospitalisation [ Time Frame: 10 year ] [ Designated as safety issue: No ]
    hospitalisation for cardiovascular reasons

  • Functional capacity assessed by NYHA functional class [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Isolated TI repair
Patients that underwent isolated tricuspid valve repair
Procedure: follow-up of isolated tricuspid valve repair
follow-up of patients that underwent TV repair in the past.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients undergoing isolated tricuspid valve repair

Criteria

Inclusion Criteria:

  • tricuspid valve insufficiency

Exclusion Criteria:

  • younger than 18 years
  • associated valvular surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537458

Contacts
Contact: Pieter De Meester, M.D. pieter.demeester@uzleuven.be

Locations
Belgium
University Hospitals Leuven Not yet recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Pieter De Meester, M.D.       pieter.demeester@uzleuven.be   
Sub-Investigator: Pieter De Meester, M.D.         
Principal Investigator: Werner Budts, M.D.; PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Agency for Science, Technology and Research
  More Information

No publications provided

Responsible Party: Pieter De Meester, M.D., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01537458     History of Changes
Other Study ID Numbers: Is_TVR_1
Study First Received: February 13, 2012
Last Updated: February 22, 2012
Health Authority: Belgium: Ethics Committee

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

ClinicalTrials.gov processed this record on September 16, 2014