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NCT02266251 · ClinicalTrials.gov registry record
Optimizing Health Outcomes in Patients With Symptomatic Aortic Valve Disease
A clinical trial of Aortic Valve Disease, sponsored by Duke University.
- Completed
- Registry status
- 273,365
- Enrollment target
- 1
- Study location
NCT02266251: Completed study of Aortic Valve Disease, sponsored by Duke University.
NCT02266251 is a study of Aortic Valve Disease that has completed, run by Duke University. The registered enrollment target is 273,365 participants, above the 393-participant average among 15 other Aortic Valve Disease trials with a reported enrollment target (69459% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02266251, a study of Aortic Valve Disease, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 273,365 participants
- Enrollment target
- 1
- Study location
Study 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 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.
Primary Outcome
All-cause mortality will be analyzed in a time-to event analysis. Mortality follow-up will be considered to be administratively censored on the last date of Medicare follow-up which is expected to be 12/31/2013 for both surgical and transcatheter AVR.
Conditions Studied
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 273,365 participants |
| Start Date | 2014-05 |
| Est. Completion | 2017-05-30 |
What the finished NCT02266251 record still lists
NCT02266251 is an observational study that tracks outcomes without assigning an intervention. Its 273,365 participants enrollment target places it among the larger protocols in the corpus, above the 393-participant average among 15 other Aortic Valve Disease trials with a reported enrollment target (69459% higher).
The record links to 1 condition, with Aortic Valve Disease appearing as the primary indexed condition, and to 0 interventions.
NCT02266251 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT02266251 about?
NCT02266251 is a clinical study titled "Optimizing Health Outcomes in Patients With Symptomatic Aortic Valve Disease". 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 ...
What is the current status of trial NCT02266251?
This trial is currently completed. The enrollment target is 273,365 participants. The study started on 2014-05. Estimated completion is 2017-05-30.
What conditions does trial NCT02266251 study?
This clinical trial studies the following conditions: Aortic Valve Disease.
Who is sponsoring clinical trial NCT02266251?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02266251 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02266251's enrollment target sits among peer trials
273,365 1st of 15 higher than 15 of 15 other Aortic Valve Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Valve Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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