AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor

Conditions

• Atrial Enlargement
• Cardiotoxicity
• Conduction Defect
• Dilated Cardiomyopathy
• HFpEF - Heart Failure With Preserved Ejection Fraction
• HFrEF - Heart Failure With Reduced Ejection Fraction
• Heart Failure
• Ischemic Heart Disease
• LV Dysfunction
• LVF
• Myocardial Infarction
• Remodeling, Cardiac
• Syncope
• Valvular Heart Disease
• Ventricular Ejection Fraction

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• 15-minutes of sitting during COR ECG Acquistion — DEVICE
  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.

Study Details

This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF) severity categories based on the American Society of Echocardiography's (ASE) 4-category scale. The software analyzes continuous ECG waveform data acquired by the FDA-cleared Peerbridge COR® ECG Wearable Monitor, an ambulatory patch device designed for use during daily activities. The AI software assists clinicians in cardiac evaluations by estimating EF severity, which reflects how well the heart pumps blood. 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.

Key Dates

Start date

Nov 21, 2024

Status verified

May 2026

Primary completion

Nov 15, 2027

Completion

Nov 15, 2027

Study Design

Enrollment

2,000 participants (estimated)

Arms

• Arm: Cohort Breakdown to Power Accuracy Assessments
  The study will enroll up to 2000 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 3 hours 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.

Primary Outcome Measure

Agreement of CorEFS Software EF Severity Categories Using Peerbridge COR™ ECG Data with ASE EF Severity Categories Established by Ultrasound Echocardiography [ Time Frame: Through study completion, average of 9 months. ]

Central Contacts

• Sandeep Gulati, PhD
  8182162958
  [email protected]
• Chris Darland, MBA
  814-572-7138
  [email protected]

Locations (8)

Find similar trials in Orange, CA

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