Status:
COMPLETED
Optimizing Health Outcomes in Patients With Symptomatic Aortic Valve Disease
Lead Sponsor:
Duke University
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
American College of Cardiology
Conditions:
Aortic Valve Disease
Eligibility:
All Genders
65+ years
Brief Summary
Disease of the aortic heart valve is both common and progressively disabling, with no effective medical treatment. In November 2011, the United States Food and Drug Administration (U.S. FDA) approved ...
Detailed Description
Aortic valve disease is a common, progressively debilitating condition with no effective medical treatment. Surgical aortic valve replacement (AVR) has been the standard of care in the presence of val...
Eligibility Criteria
Inclusion
- 'operable' transcatheter AVR patients enrolled in the TVT Registry (Nov 2011 -Dec 2013)
- surgical AVR patients with a STS perioperative risk of mortality (PROM) ≥4% whose index procedure is included in the STS ACSD (Jan 2011 - Dec 2013)
Exclusion
- We will exclude patients with endocarditis or emergency/salvage status because these patients are rarely treated using transcatheter AVR in the United States (\<0.2% incidence of either condition during the first year of TVT Registry data).
Key Trial Info
Start Date :
May 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 30 2017
Estimated Enrollment :
273365 Patients enrolled
Trial Details
Trial ID
NCT02266251
Start Date
May 1 2014
End Date
May 30 2017
Last Update
October 13 2017
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27705