Choice of Valve Substitute in the Era of Oral Anticoagulation Self-Management

This study has been completed.
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01269905
First received: January 3, 2011
Last updated: NA
Last verified: January 2005
History: No changes posted
  Purpose
The optimal valve substitute for patients between 60-70 years is controversial. We compared anticoagulation-related adverse events (ARAE) in patients receiving mechanical heart valve replacement (MHVR) on INR self-management vs. stentless bioprosthesis, to assess whether the risk of structural valve deterioration (SVD) is still out-weighted by the benefit of not requiring permanent anticoagulation.

Condition
Anticoagulation
Mechanical Heart Valve Replacement

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Groups/Cohorts
Group A
Group A patients received mechanical heart valve replacement MHVR (and were educated in INR self-management using the Coagu-Check monitor.
Group B
Group B patients received MHVR and their anticoagulation was managed by their general practitioners.
Group C
Group C patients received stentless bioprosthesis, with initial 6 weeks on oral anticoagulation managed by their general practitioners.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients received heart valve replacement and were retrospectively allocated in three groups
Criteria

Inclusion Criteria:

  • heart valve replacement

Exclusion Criteria:

  • CABG
  • Afib
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT01269905     History of Changes
Other Study ID Numbers: COAG-001 
Study First Received: January 3, 2011
Last Updated: January 3, 2011
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on July 21, 2016