Status:
COMPLETED
Improved Time in Therapeutic Range With Patient Self-Testing of Their INR Compared to Usual Care
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
LivaNova
Conditions:
Management of Anticoagulation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients who receive a mechanical heart valve to replace a diseased heart valve must take an anticoagulation medicine the rest of their lives, and monitor their level of anticoagulation. Until recentl...
Detailed Description
Prosthetic replacement of diseased heart valves is a routine procedure, and mechanical heart valves have excellent hemodynamic performance and durability. However, mechanical valves are thrombogenic, ...
Eligibility Criteria
Inclusion
- Patients that received a mechanical valve while in our hospital
- Age \> 18 years
Exclusion
- Pregnant or lactating women
- Patients that have genetic clotting disorders such as Factor 5
- Physical disabilities (for example, poor eyesight, tremor, or other neurological disability) that would prevent the patient from being able to perform finger stick blood sampling. (Patients may not be excluded for physical disabilities if a care giver is willing to learn and assist with performing patient self-testing.)
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00703963
Start Date
March 1 2007
End Date
March 1 2009
Last Update
August 28 2014
Active Locations (1)
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1
Saint Marys Hospital
Rochester, Minnesota, United States, 55906