Status:
COMPLETED
Randomized On-X Anticoagulation Trial
Lead Sponsor:
On-X Life Technologies, Inc.
Collaborating Sponsors:
Clinipace Worldwide
Acelis Connected Health
Conditions:
Heart Valve Disease
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Various patient groups with the On-X Valve can be maintained safely on lower doses of blood thinner(Coumadin®) or on antiplatelet drugs (aspirin/Plavix®) only rather than the standard dose of Coumadin...
Detailed Description
This is a longitudinal, randomized (randomization to occur at the 3-month follow-up) study comparing the On-X valve on low dose anticoagulation (test group) to concomitant control groups of On-X valve...
Eligibility Criteria
Inclusion
- Patients requiring isolated aortic valve replacement (AVR), or isolated mitral valve replacement (MVR).
- AVR patients receiving low dose or antiplatelet only anticoagulation will be divided into groups at low risk and high risk for thromboembolism with all patients being in the low risk group except for patients with the following conditions which place a patient in the high risk group:
- Chronic atrial fibrillation
- Left ventricular ejection fraction \< 30 %
- Enlarged left atrium \>50mm diameter
- Spontaneous echo contrasts in the left atrium
- Vascular pathology
- Neurological events
- Hypercoagulability
- Left or right ventricular aneurysm
- Lack of platelet response to aspirin or clopidogrel
- Women receiving estrogen replacement therapy
- Concomitant cardiac surgery is allowed
- Adult patients
Exclusion
- Right side valve replacement
- Double (aortic plus mitral) valve replacement
- Patients with active endocarditis at the time of implant
- Previous confirmed or suspected thromboembolic event or thrombophlebitis
- Other terminal illness
- Patients who are in an emergency state
- Inability to return for required follow-ups
- Patients with an On-X valve implanted within the study and subsequently explanted
- Patients who are known to be pregnant, plan to become pregnant or are lactating
- Patients with acquired immunodeficiency syndrome or know to be HIV positive
- Patients who are prison inmates or known drug or alcohol abusers
- Patients unable to give adequate informed consent.
Key Trial Info
Start Date :
June 6 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2023
Estimated Enrollment :
977 Patients enrolled
Trial Details
Trial ID
NCT00291525
Start Date
June 6 2006
End Date
December 29 2023
Last Update
December 24 2024
Active Locations (49)
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1
Tucson Medical Center
Tucson, Arizona, United States, 85718
2
Southern Arizona VA Medical Center
Tucson, Arizona, United States, 85723
3
Loma Linda University
Loma Linda, California, United States, 92354
4
Hartford Hospital
Hartford, Connecticut, United States, 06102