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

Anticoagulation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01269905
• Other study ID #: COAG-001
• Status: Completed
• Phase: N/A
• First received: January 3, 2011
• Last updated: January 3, 2011

Study information

• Verified date: January 2005
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• heart valve replacement

Exclusion Criteria:

• CABG

• Afib

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Anticoagulation
• Mechanical Heart Valve Replacement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals