Status:

UNKNOWN

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

Lead Sponsor:

Minneapolis Heart Institute Foundation

Conditions:

Disparities in Treatment of Aortic Valve Stenosis

Aortic Valve Stenosis

Eligibility:

All Genders

18+ years

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 comorbid...

Eligibility Criteria

Inclusion

  • 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

  • Age \< 18
  • Patients who do not allow their records to be used for research

Key Trial Info

Start Date :

June 4 2018

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

August 1 2022

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT04525937

Start Date

June 4 2018

End Date

August 1 2022

Last Update

April 8 2022

Active Locations (1)

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1

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States, 55407