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Long-term Outcome After Isolated Tricuspid Valve Repair

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Pieter De Meester, Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01537458
First Posted: February 23, 2012
Last Update Posted: February 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Agency for Science, Technology and Research
Information provided by (Responsible Party):
Pieter De Meester, Universitaire Ziekenhuizen Leuven
  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 Pieter De Meester, Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • mortality [ Time Frame: 10 year ]
  • Redo surgery [ Time Frame: 10 year ]

Secondary Outcome Measures:
  • functional capacity assessed by CPET [ Time Frame: 10 year ]
  • Atrial fibrillation [ Time Frame: 10 year ]
  • Hospitalisation [ Time Frame: 10 year ]
    hospitalisation for cardiovascular reasons

  • Functional capacity assessed by NYHA functional class [ Time Frame: 10 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Pieter De Meester, M.D., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01537458     History of Changes
Other Study ID Numbers: Is_TVR_1
First Submitted: February 13, 2012
First Posted: February 23, 2012
Last Update Posted: February 23, 2012
Last Verified: February 2012

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