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

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. Identifier: NCT01269905
Recruitment Status : Completed
First Posted : January 4, 2011
Last Update Posted : January 4, 2011
Information provided by:
Johann Wolfgang Goethe University Hospital

Brief Summary:
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 or disease
Anticoagulation Mechanical Heart Valve Replacement

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

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.

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

Inclusion Criteria:

  • heart valve replacement

Exclusion Criteria:

  • CABG
  • Afib Identifier: NCT01269905     History of Changes
Other Study ID Numbers: COAG-001
First Posted: January 4, 2011    Key Record Dates
Last Update Posted: January 4, 2011
Last Verified: January 2005