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Optimizing Health Outcomes in Patients With Symptomatic Aortic Valve Disease

NCT02266251 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 273365

Last updated 2017-10-13

No results posted yet for this 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.

Conditions

  • Aortic Valve Disease

Sponsors & Collaborators

Principal Investigators

  • James M Brennan, MD, MPH · Duke Clinical Research Institute

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-04-30
Completion
2017-05-30

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02266251 on ClinicalTrials.gov