This site became the new on June 19th. Learn more.
Show more 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... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Johann Wolfgang Goethe University Hospital Identifier:
First received: January 3, 2011
Last updated: NA
Last verified: January 2005
History: No changes posted
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.

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 Hospital:

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.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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
  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.

No Contacts or Locations Provided
  More Information Identifier: NCT01269905     History of Changes
Other Study ID Numbers: COAG-001
Study First Received: January 3, 2011
Last Updated: January 3, 2011 processed this record on September 21, 2017