AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor
NCT ID: NCT06699056
Last Updated: 2025-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1500 participants
OBSERVATIONAL
2024-11-21
2025-09-30
Brief Summary
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In this study, EF severity determination will be made using 5-minute ECG recordings collected during a 15-minute resting period with participants seated upright. The results will be compared to EF severity obtained from an FDA-cleared, non-contrast transthoracic echocardiogram (TTE) predicate device. This comparison aims to validate the accuracy of the AI software.
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Detailed Description
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Background Heart failure (HF) remains a significant public health issue, particularly in older adults (75+), with high morbidity and mortality rates. Half of HF cases involve reduced EF (HFrEF), a condition associated with a 75% five-year mortality rate. Despite advancements in HF management, accessible, low-cost EF monitoring is lacking.
Echocardiography (Echo) is the gold standard for EF measurement but is limited in ambulatory and home settings. Continuous ECG wearables like the Peerbridge Cor® offer a promising alternative, providing high diagnostic yield, low wear burden, and real-time EF estimation. Previous studies (References 1-11) demonstrate the potential of AI-enabled ECG analysis in EF prediction, with accuracies up to 91.4% and AUCs of 0.94 in estimating EF severity.
Successful demonstration of the proposed endpoints to clinically acceptable statistical thresholds will provide a new and alternative capability for EF severity assessments compared to ultrasound, MRI, and other imaging modalities where access is limited.
Hypothesis Specific ECG changes may identify left ventricular dysfunction (LVSD) and predict EF severity, enabling low-burden, cost-effective EF monitoring in high-risk populations.
Study Design
Participant Enrollment and Setup
Participants will receive the Peerbridge Cor® wearable, with data collection occurring through:
In-clinic setup: Study staff apply and initiate device use. Patient Home Setup (PHS): Telehealth guidance for independent device application (20% of participants).
Subprotocols
A: 30 minutes of Cor® ECG recording; 15 minutes analyzed. B: Up to 7 days of Cor® device use with periodic 15-minute sitting sessions. EF Reference Standard EF severity will be determined via FDA-cleared transthoracic echocardiography (TTE), using the Simpson's Bi-Plane Method.
Data Collection
Peerbridge Cor® ECG Data: 30 minutes recorded; 15 minutes analyzed in 5-minute segments.
Echo Study: Conducted before or during Cor® recording. 12-Lead ECG: Simultaneous recording with the Cor® device. Participants log sessions using the Cor® device's Event button. De-identified medical histories will support subgroup analyses.
Endpoints Agreement between Cor® ECG-derived EF severity and Echo results will be assessed across ASE-defined categories (Normal, Mild, Moderate, Severe). Positive predictive value (PPV) adjusted for prevalence will be calculated.
This streamlined protocol validates CorEFS software for reliable, cost-effective EF monitoring and clinical decision support.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort Breakdown to Power Accuracy Assessments
The study will enroll up to 1,500 participants across Subprotocol A and B, with a predictive total cohort of at least 660 unique participants. Each participant must provide at least one valid paired data point, defined as ECHO results paired with at least 30 minutes of Peerbridge COR™ ECG data, acquired concurrently or within 60 minutes of ECHO completion. Enrollment will occur at a minimum of 3 trial sites, with data collection ensuring at least 165 valid paired points per EF Severity category, as determined by the reference ECHO, from different participants.
A paired data point is considered invalid if all 5-minute sitting windows during a 15-minute session yield "Not Analyzable" outputs. Participants who do not comply with the protocol or do not yield valid paired data points will be excluded from analysis and study statistics. Trial site investigators may use institutional EMR databases to identify, qualify, and recruit participants from their community patient populations.
15-minutes of sitting during COR ECG Acquistion
Participants will follow a standardized protocol during a 15-minute seated session using the Peerbridge COR™ device. Participants will sit comfortably in an upright chair with a straight back; armrests are optional. Their feet must remain flat on the floor with legs uncrossed to ensure unobstructed blood flow and a stable posture. Arms should be relaxed and placed in their lap, on a flat surface (e.g., table), or on the armrest, ensuring they are not tensed or elevated. Participants will maintain a straight back with relaxed shoulders throughout the session.
To begin, participants will press the Event Button on the Peerbridge COR™ mobile device, marking the start of the session. They will remain seated in this position for 15 minutes. At the end of the session, participants will press the Event Button again to mark the conclusion of the seated event. This protocol ensures consistent data collection across all participants.
Interventions
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15-minutes of sitting during COR ECG Acquistion
Participants will follow a standardized protocol during a 15-minute seated session using the Peerbridge COR™ device. Participants will sit comfortably in an upright chair with a straight back; armrests are optional. Their feet must remain flat on the floor with legs uncrossed to ensure unobstructed blood flow and a stable posture. Arms should be relaxed and placed in their lap, on a flat surface (e.g., table), or on the armrest, ensuring they are not tensed or elevated. Participants will maintain a straight back with relaxed shoulders throughout the session.
To begin, participants will press the Event Button on the Peerbridge COR™ mobile device, marking the start of the session. They will remain seated in this position for 15 minutes. At the end of the session, participants will press the Event Button again to mark the conclusion of the seated event. This protocol ensures consistent data collection across all participants.
Eligibility Criteria
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Inclusion Criteria
* Able and eligible to wear a Holter monitor
Exclusion Criteria
* Any condition that, in the investigator's opinion, could interfere with compliance with the study protocol or pose a safety risk to the participant
* History of poor tolerance or severe skin reactions to ECG adhesive materials
18 Years
ALL
Yes
Sponsors
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Peerbridge Health, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Andrea Natale, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Cardiac Arrhythmia Research Foundation
Johanna P Contreras, MD
Role: PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL
Sachin Parikh, MD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Hospital
Brian Kolski, MD
Role: PRINCIPAL_INVESTIGATOR
Orange County Heart Institute
Daniel Bensimhon, MD
Role: PRINCIPAL_INVESTIGATOR
Moses H. Cone Memorial Hospital
Sandeep Gulati, PhD
Role: PRINCIPAL_INVESTIGATOR
Peerbridge Health, Inc
Frank Mazzola, MD
Role: PRINCIPAL_INVESTIGATOR
South Heart Clinic
Sameer Jamal, MD
Role: PRINCIPAL_INVESTIGATOR
Hackensack Meridian Health
Locations
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Orange County Heart Institute
Orange, California, United States
Peerbridge Health
Melbourne, Florida, United States
Henry Ford Hospital
Detroit, Michigan, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Mount Sinai Hospital
New York, New York, United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
South Heart Clinic
Weslaco, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Murtagh G, Dawkins IR, O'Connell R, Badabhagni M, Patel A, Tallon E, O'Hanlon R, Ledwidge MT, McDonald KM. Screening to prevent heart failure (STOP-HF): expanding the focus beyond asymptomatic left ventricular systolic dysfunction. Eur J Heart Fail. 2012 May;14(5):480-6. doi: 10.1093/eurjhf/hfs030. Epub 2012 Mar 13.
Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.
Alhamaydeh M, Gregg R, Ahmad A, Faramand Z, Saba S, Al-Zaiti S. Identifying the most important ECG predictors of reduced ejection fraction in patients with suspected acute coronary syndrome. J Electrocardiol. 2020 Jul-Aug;61:81-85. doi: 10.1016/j.jelectrocard.2020.06.003. Epub 2020 Jun 5.
O'Neal WT, Mazur M, Bertoni AG, Bluemke DA, Al-Mallah MH, Lima JAC, Kitzman D, Soliman EZ. Electrocardiographic Predictors of Heart Failure With Reduced Versus Preserved Ejection Fraction: The Multi-Ethnic Study of Atherosclerosis. J Am Heart Assoc. 2017 May 25;6(6):e006023. doi: 10.1161/JAHA.117.006023.
Chen HY, Lin CS, Fang WH, Lou YS, Cheng CC, Lee CC, Lin C. Artificial Intelligence-Enabled Electrocardiography Predicts Left Ventricular Dysfunction and Future Cardiovascular Outcomes: A Retrospective Analysis. J Pers Med. 2022 Mar 13;12(3):455. doi: 10.3390/jpm12030455.
Adedinsewo D, Carter RE, Attia Z, Johnson P, Kashou AH, Dugan JL, Albus M, Sheele JM, Bellolio F, Friedman PA, Lopez-Jimenez F, Noseworthy PA. Artificial Intelligence-Enabled ECG Algorithm to Identify Patients With Left Ventricular Systolic Dysfunction Presenting to the Emergency Department With Dyspnea. Circ Arrhythm Electrophysiol. 2020 Aug;13(8):e008437. doi: 10.1161/CIRCEP.120.008437. Epub 2020 Aug 4.
Yao X, Rushlow DR, Inselman JW, McCoy RG, Thacher TD, Behnken EM, Bernard ME, Rosas SL, Akfaly A, Misra A, Molling PE, Krien JS, Foss RM, Barry BA, Siontis KC, Kapa S, Pellikka PA, Lopez-Jimenez F, Attia ZI, Shah ND, Friedman PA, Noseworthy PA. Artificial intelligence-enabled electrocardiograms for identification of patients with low ejection fraction: a pragmatic, randomized clinical trial. Nat Med. 2021 May;27(5):815-819. doi: 10.1038/s41591-021-01335-4. Epub 2021 May 6.
Sangha V, Nargesi AA, Dhingra LS, Khunte A, Mortazavi BJ, Ribeiro AH, Banina E, Adeola O, Garg N, Brandt CA, Miller EJ, Ribeiro ALP, Velazquez EJ, Giatti L, Barreto SM, Foppa M, Yuan N, Ouyang D, Krumholz HM, Khera R. Detection of Left Ventricular Systolic Dysfunction From Electrocardiographic Images. Circulation. 2023 Aug 29;148(9):765-777. doi: 10.1161/CIRCULATIONAHA.122.062646. Epub 2023 Jul 25.
Bachtiger P, Petri CF, Scott FE, Ri Park S, Kelshiker MA, Sahemey HK, Dumea B, Alquero R, Padam PS, Hatrick IR, Ali A, Ribeiro M, Cheung WS, Bual N, Rana B, Shun-Shin M, Kramer DB, Fragoyannis A, Keene D, Plymen CM, Peters NS. Point-of-care screening for heart failure with reduced ejection fraction using artificial intelligence during ECG-enabled stethoscope examination in London, UK: a prospective, observational, multicentre study. Lancet Digit Health. 2022 Feb;4(2):e117-e125. doi: 10.1016/S2589-7500(21)00256-9. Epub 2022 Jan 5.
Al Younis SM, Hadjileontiadis LJ, Khandoker AH, Stefanini C, Soulaidopoulos S, Arsenos P, Doundoulakis I, Gatzoulis KA, Tsioufis K. Prediction of heart failure patients with distinct left ventricular ejection fraction levels using circadian ECG features and machine learning. PLoS One. 2024 May 13;19(5):e0302639. doi: 10.1371/journal.pone.0302639. eCollection 2024.
Garcia-Escobar A, Vera-Vera S, Jurado-Roman A, Jimenez-Valero S, Galeote G, Moreno R. Subtle QRS changes are associated with reduced ejection fraction, diastolic dysfunction, and heart failure development and therapy responsiveness: Applications for artificial intelligence to ECG. Ann Noninvasive Electrocardiol. 2022 Nov;27(6):e12998. doi: 10.1111/anec.12998. Epub 2022 Jul 29.
Other Identifiers
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PBH-COREFS-1-A
Identifier Type: OTHER
Identifier Source: secondary_id
PBH-COREFS-1-A
Identifier Type: -
Identifier Source: org_study_id
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