This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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:
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 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

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
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

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

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

ClinicalTrials.gov processed this record on June 27, 2017