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

NCT ID: NCT01269905

Last Updated: 2011-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Brief Summary

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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.

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Detailed Description

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Conditions

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Anticoagulation Mechanical Heart Valve Replacement

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group A

Group A patients received mechanical heart valve replacement MHVR (and were educated in INR self-management using the Coagu-Check monitor.

No interventions assigned to this group

Group B

Group B patients received MHVR and their anticoagulation was managed by their general practitioners.

No interventions assigned to this group

Group C

Group C patients received stentless bioprosthesis, with initial 6 weeks on oral anticoagulation managed by their general practitioners.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* heart valve replacement

Exclusion Criteria

* CABG
* Afib
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Other Identifiers

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COAG-001

Identifier Type: -

Identifier Source: org_study_id

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