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  • May 05, 2021

Mayo Clinic Site Feasibility Questionnaire: A Multicenter Study of Detection of Low Ventricular Ejection Fraction (LVEF)

Mayo Clinic is seeking collaborators to participate in a retrospective validation study of an ECG-based artificial intelligence algorithm for the detection of low left ventricular ejection fraction (LVEF) that we have previously developed[i]. The validation results will be submitted to the FDA as part of a De Novo software as a medical device (SAMD) application. This study is fully funded by Mayo Clinic and an opportunity to develop a long-term academic collaboration for future validation studies and publications.

Investigators from participating sites will have full authorship in all resulting research publications from this external validation study.

Site Requirements:

  • Ability to access and send 12-lead ECG data in raw digital format (.csv or .xml files).
  • Provide 3000+ ECGs from patients who have one or more risk factors for heart failure with a corresponding echocardiogram within 14 days of the ECG
  • Ability to automate extraction of demographic information and clinical risk factors for heart failure from the EMR
  • The LVEF must be estimated using the Simpson biplane method and a process should be in place to exclude any LVEF estimations calculated via a different method
  • Ability to complete the agreement, IRB approval and study execution in a short timeframe

If you have an interest in participating or would like to learn more, please contact RSTCVINN@mayo.edu.

Download Questionnaire

[1] Attia ZI, Kapa S, Lopez-Jimenez F, McKie PM, Ladewig DJ, Satam G, Pellikka PA, Enriquez-Sarano M, Noseworthy PA, Munger TM, Asirvatham SJ, Scott CG, Carter RE, Friedman PA. Screening for cardiac contractile dysfunction using an artificial intelligence-enabled electrocardiogram. Nat Med. 2019 Jan;25(1):70-74. doi: 10.1038/s41591-018-0240-2. Epub 2019 Jan 7. PMID: 30617318.

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