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

J

Johann Wolfgang Goethe University Hospital

Status

Completed

Conditions

Anticoagulation
Mechanical Heart Valve Replacement

Study type

Observational

Funder types

Other

Identifiers

NCT01269905
COAG-001

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

heart valve replacement

Exclusion criteria

  • CABG
  • Afib

Trial design

0 participants in 3 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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