A Multi-Center Study of Detection of Low Ventricular Ejection Fraction
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|ClinicalTrials.gov Identifier: NCT04963218|
Recruitment Status : Completed
First Posted : July 15, 2021
Last Update Posted : July 13, 2022
|Condition or disease||Intervention/treatment|
|Cardiac Disease||Diagnostic Test: AI Algorithm to detect LVEF in ECG|
Following institutional review board approval, 12,000 12-lead ECG's paired with an echocardiogram with LVEF information within 30 days of the date of the ECG will be collected across three enrolled sites. Each site will provide data from up to 4000 enrolled subjects that meet the inclusion criteria. No other demographic characteristics or enrichment will be considered in the selection of subjects in order to best represent the general population for that site. Sites will securely transfer the data to a centralized repository for processing.
Once data is collected, the device will be used to analyze the ECG data for all enrolled subjects without reference or access to the echocardiogram data. The device will display a binary 36 prediction of the likelihood of LVEF less than or equal to 40%. Results will be compared to the echocardiogram reference standard in accordance with the statistical analysis plan.
|Study Type :||Observational|
|Actual Enrollment :||16000 participants|
|Official Title:||A Multicenter Study of Detection of Low Ventricular Ejection Fraction (LVEF) ≤ 40% Based on Point-of-Care 12- Lead ECG Data|
|Actual Study Start Date :||August 30, 2021|
|Actual Primary Completion Date :||April 13, 2022|
|Actual Study Completion Date :||April 13, 2022|
- Diagnostic Test: AI Algorithm to detect LVEF in ECG
A clinical decision support software as a medical device that detects whether a patient has LVEF less than or equal to 40% based upon the input of one or more ECG vectors at the point-of-care.
- Established Diagnostic Performance [ Time Frame: 1 month ]Number of participants with presence of EF less than of equal to 40% identified by 12-lead AI ECG algorithm
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04963218
|United States, Massachusetts|
|Beth Israel Deacon Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|United States, South Dakota|
|Rapid City, South Dakota, United States, 57701|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Peter Noseworthy, MD||Mayo Clinic|