Recruiting

Observational Study

Sponsor:

Minneapolis Heart Institute Foundation

Code:

NCT04525937

Conditions

Disparities in Treatment of Aortic Valve Stenosis

Aortic Valve Stenosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Patient Questionnaire

Provider Questionnaire

Study Details

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.

Conditions

Disparities in Treatment of Aortic Valve Stenosis

Aortic Valve Stenosis

Study ID

NCT04525937

Start date

Jun 4, 2018

Status verified date

Apr, 2022

Completion date

Aug 1, 2022

Anticipated

Primary completion date

Aug 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with Severe Aortic Stenosis with Disparities

Patients will complete a survey and their aortic stenosis will be clinically followed at 30 days and one year

Medical Providers with Disparities

Referring primary care providers complete a questionnaire on their referral practices for patients with severe aortic stenosis

Interventions

Patient Questionnaire

Patient Questionnaire

Provider Questionnaire

Provider Questionnaire

Primary outcome measure

  • Patient Mortality [ Time Frame: 30 days and 1 year ]
  • MACE (Major Adverse Cardiac Event) [ Time Frame: 30 days and 1 year ]

Central Contacts and Locations

Central contacts

Locations

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

More Information

Sponsor

Minneapolis Heart Institute Foundation

Last update posted

Apr 8, 2022

Last verified

Apr, 2022

Keywords

  • Aortic Valve Stenosis
  • Disparities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Minneapolis Heart Institute Foundation on 2022-04-08.