Brief Title
Racial and Economic Disparities and Unmet Needs in Patients With Severe Aortic Valvular Disease
Official Title
Racial and Economic Disparities and Unmet Needs in Patients With Severe Aortic Valvular Disease
Brief Summary
Common barriers to receiving appropriate guideline-driven care for patients with severe aortic stenosis include referral biases by primary care providers (lack of provider education), patient comorbidities (degree of fragility), as well as psychosocial issues and cultural barriers. Additionally, race, ethnicity, socioeconomic status (SES) and education level are shown to be persistent barriers to accessing healthcare services and healthcare systems, creating a significant practice gap between various patient populations. The most recent transcatheter valve therapies (TVT) registry data show that >94% of TAVR recipients are Caucasian, followed by less than 4% of African-Americans and Hispanics, respectively. There is a critical need to understand the barriers to treatment and care among severe aortic valve disease patients of disparate groups. This study is a multi-center, retrospective and prospective cohort study of patients diagnosed with severe aortic stenosis. Additionally, we will be surveying referring primary care providers, cardiologists and cardiovascular surgeons to assess their current referral practices for patients with severe aortic stenosis.
Study Type
Observational
Primary Outcome
Patient Mortality
Secondary Outcome
Referring physician- related barriers/biases.
Condition
Disparities in Treatment of Aortic Valve Stenosis
Intervention
Patient Questionnaire
Study Arms / Comparison Groups
Patients with Severe Aortic Stenosis with Disparities
Description: Patients will complete a survey and their aortic stenosis will be clinically followed at 30 days and one year
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
200
Start Date
June 4, 2018
Completion Date
August 1, 2022
Primary Completion Date
August 1, 2022
Eligibility Criteria
Inclusion Criteria: - Disparity/Diversity background (either race/ethnicity, low SES (adults with incomes at or below the federal poverty level (family income to poverty ratio, ≤1), language (non-English speaker) or education (≤9 years of education)) - Patient scheduled for transcatheter aortic valve replacement using the Edwards Sapien valve, OR recently implanted with Edwards Sapien valve (up to 1 year post-TAVR) - Echocardiographic diagnosis of severe, symptomatic AS and intermediate to high surgical risk per Society of Thoracic Surgeons (STS) mortality risk-score Exclusion Criteria: - Age < 18 - Patients who do not allow their records to be used for research
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Mario Goessl, MD, PhD, 612-863-3833, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04525937
Organization ID
Racial Disparities
Responsible Party
Sponsor
Study Sponsor
Minneapolis Heart Institute Foundation
Study Sponsor
Mario Goessl, MD, PhD, Principal Investigator, Minneapolis Heart Institute Foundation
Verification Date
August 2020