Optimizing Health Outcomes in Patients With Symptomatic Aortic Valve Disease
Completed
Conditions studied: Aortic Valve Disease
In brief
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 a new, less invasive transcatheter alternative to surgical aortic valve replacement (AVR). This new technology has changed the treatment of patients with aortic valve disease. In doing so, it has created a pressing clinical need for shared decision making tools that will help patients understand the risks and benefits of each treatment alternative in the setting of their individual characteristics. The overarching goal of this study is to develop a new way to approach the treatment of medical illness, by focusing on the expected treatment outcomes for individual patients using information collected from large groups of patients. The corner-stone of this model is a public website that is designed to engage patients and clinicians in a personalized discussion of treatment alternatives. To achieve this goal for patients with aortic valve disease, we will use existing clinical data from the Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) national procedural registries that has been linked to Medicare claims for patient follow-up to 1) evaluate important health outcomes with surgical versus transcatheter AVR among patients who would be eligible for surgical AVR, and 2) create and evaluate personalized decision assistance tools for all patients considering AVR. This work will be accomplished in direct partnership with both patients and caregivers as well as a diverse group of stakeholders who will help ensure its usefulness and dissemination.
Key facts
- Study ID
- NCT02266251
- Run by
- Duke University
- People needed
- 273365
- Starts
- 2014-05-01
- Expected to finish
- 2017-05-30
- Last updated by the study team
- 2017-10-13
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- '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)
You may not qualify if…
- 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).
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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