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Racial and Economic Disparities and Unmet Needs in Patients With Severe Aortic Valvular Disease

Racial and Economic Disparities and Unmet Needs in Patients With Severe Aortic Valvular Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04525937
Enrollment
200
Registered
2020-08-25
Start date
2018-06-04
Completion date
2022-08-01
Last updated
2022-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disparities in Treatment of Aortic Valve Stenosis, Aortic Valve Stenosis

Keywords

Aortic Valve Stenosis, Disparities

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.

Interventions

Patient Questionnaire

OTHERProvider Questionnaire

Provider Questionnaire

Sponsors

Minneapolis Heart Institute Foundation
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Patient Mortality30 days and 1 year
MACE (Major Adverse Cardiac Event)30 days and 1 year

Secondary

MeasureTime frameDescription
Referring physician- related barriers/biases.through study completion, an average of 1 yearSecondary outcomes (Providers): referring physician-related barriers/biases against routine guideline-driven care for members of disparate groups with severe aortic stenosis.

Countries

United States

Contacts

Primary ContactSarah Schwager, RN, BSN
Sarah.Schwager@allina.com612-863-6257

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026