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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Age ≥ 18 years

• Able and eligible to wear a Holter monitor

Locations
United States
California
Orange County Heart Institute
RECRUITING
Orange
Florida
Peerbridge Health
NOT_YET_RECRUITING
Melbourne
Michigan
Henry Ford Hospital
RECRUITING
Detroit
North Carolina
Moses H. Cone Memorial Hospital
RECRUITING
Greensboro
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
New York
Mount Sinai Hospital
RECRUITING
New York
Texas
Texas Cardiac Arrhythmia Research Foundation
RECRUITING
Austin
South Heart Clinic
RECRUITING
Weslaco
Contact Information
Primary
Sandeep Gulati, PhD
s.gulati@peerbridgehealth.com
8182162958
Backup
Chris Darland, MBA
c.darland@peerbridgehealth.com
814-572-7138
Time Frame
Start Date: 2024-11-21
Estimated Completion Date: 2025-09
Participants
Target number of participants: 1500
Treatments
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.
Sponsors
Leads: Peerbridge Health, Inc

This content was sourced from clinicaltrials.gov