Clinical research needs you

Women & minorities are underrepresented in clinical research

Why you should participate in a cardiovascular device trial

Clinical research should reflect the population it intends to treat

By participating you can help in the development of lifesaving treatments

Play a part in advancing innovation in medical devices

Gender and ethnic differences matter in treatment of heart valve disease

52% of women surveyed experienced heart valve disease symptoms1

Low-income patients receive less care2

Women are less likely than men to receive treatment for symptomatic severe aortic stenosis (AS)3

Different risk profiles.
Different treatment outcomes.

With your help participating in Clinical Trials, we can explore whether a treatment approach or device is safe and effective. Data show that women are getting referred later than men4, and increasing female participation is critical to improving our understanding about the effects of new treatments for women and saving lives.

We need you.

Have similar Aortic Stenosis severity with less valve calcification More severe exertional dyspnea Higher frailty
different risks infographic Women5-7
Women scheduled for Aortic Valve replacement were significantly older Smaller body size.
Smaller valve size
More severe AS

Effectiveness and safety may differ among population subgroups depending on intrinsic/extrinsic factors, including:

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Race

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Ethnicity

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Sex

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Lifestyle

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Age

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Genetic background

Did you know?

More ethnic minority participation is needed in clinical trials

With your help we can do better...

Representation across 178 cardiovascular clinical trials9

White 73%
Hispanic or Latino 11%
Asian 10%
Black or African American 4%
Other 2%

Although Edwards has increased diverse ethnic participation in the PARTNER series clinical trials from 2007-2017, there is still more progress to be made.

Take your health to heart

Talk to your doctor to see if a clinical trial is right for you.

For more information, contact us or reach out to our dedicated Edwards team members.

References

  1. WomenHeart. “Heart Valve Disease – Why We Under-Diagnose and Under-Treat Women” # Accessed August 24, 2021.
  2. Bob-Manuel T, Sharma A, Nanda A, Ardeshna D, Skelton IV WP, Khouzam RN. A review of racial disparities in transcatheter aortic valve replacement (TAVR): accessibility, referrals and implantation. Annals of Translational Medicine. 2018 Jan;6(1).
  3. Lowenstern A, Sheridan P, Wang TY, Boero I, Vemulapalli S, Thourani VH, Leon MB, Peterson ED, Brennan JM. Sex disparities in patients with symptomatic severe aortic stenosis. American Heart Journal. 2021 Jul 1;237:116-26.
  4. Michos ED, Reddy TK, Gulati M, Brewer LC, Bond RM, Velarde GP, Bailey AL, Echols MR, Nasser SA, Bays HE, Navar AM. Improving the enrollment of women and racially/ethnically diverse populations in cardiovascular clinical trials: An ASPC practice statement. American Journal of Preventive Cardiology. 2021 Aug 20:100250.
  5. Nitsche C, Koschutnik M, Kammerlander A, Hengstenberg C, Mascherbauer J. Gender-specific differences in valvular heart disease. Wiener klinische Wochenschrift. 2020 Feb;132(3):61-8.
  6. Aggarwal SR, Clavel MA, Messika-Zeitoun D, Cueff C, Malouf J, Araoz PA, Mankad R, Michelena H, Vahanian A, Enriquez-Sarano M. Sex differences in aortic valve calcification measured by multidetector computed tomography in aortic stenosis. Circulation: Cardiovascular Imaging. 2013 Jan;6(1):40-7.
  7. Caponcello MG, Banderas LM, Ferrero C, Bramlage C, Thoenes M, Bramlage P. Gender differences in aortic valve replacement: is surgical aortic valve replacement riskier and transcatheter aortic valve replacement safer in women than in men?. Journal of Thoracic Disease. 2020 Jul;12(7):3737.
  8. Lindman BR, Arnold SV, Bagur R, Clarke L, Coylewright M, Evans F, Hung J, Lauck SB, Peschin S, Sachdev V, Tate LM. Priorities for Patient‐Centered Research in Valvular Heart Disease: A Report From the National Heart, Lung, and Blood Institute Working Group. Journal of the American Heart Association. 2020 May 5;9(9):e015975.
  9. Preventza O, Critsinelis A, Simpson K, Olive JK, LeMaire SA, Cornwell LD, Jimenez E, Byrne J, Chatterjee S, Rosengart TK, Coselli JS. Sex, racial, and ethnic disparities in US cardiovascular trials in more than 230,000 patients. The Annals of Thoracic Surgery. 2021 Sep 1;112(3):726-35.