Recruiting

AI Software

Sponsor:

Peerbridge Health, Inc

Code:

NCT06699056

Conditions

Ventricular Ejection Fraction

LVF

LV Dysfunction

Atrial Enlargement

Conduction Defect

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

15-minutes of sitting during COR ECG Acquistion

Study Details

Brief 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.

Conditions

Ventricular Ejection Fraction

LVF

LV Dysfunction

Atrial Enlargement

Conduction Defect

Study ID

NCT06699056

Start date

Nov 21, 2024

Status verified date

May, 2026

Completion date

Nov 15, 2027

Anticipated

Primary completion date

Nov 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age ≥ 18 years
  • Able and eligible to wear a Holter monitor

Exclusion Criteria:

  • Receiving mechanical respiratory or circulatory support, or renal support therapy, at the time of screening or during Visit #1
  • 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

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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 and Locations

Central contacts

Sandeep Gulati, PhD

8182162958s.gulati@peerbridgehealth.com

Chris Darland, MBA

814-572-7138c.darland@peerbridgehealth.com

Locations

Orange County Heart Institute

Recruiting

Orange, California, United States, 92868

Contacts

Brian Kolski, MD

(714) 564-3300bkolskimd@gmail.com

Principal Investigator:

Brian Kolski, MD

Peerbridge Health

Recruiting

Pasadena, California, United States, 91107

Contacts

Sandeep Gulati, PhD

877-960-0332s.gulati@peerbridgehealth.com

Lauren Pickard, MS

l.pickard@peerbridgehealth.com

Principal Investigator:

Sandeep Gulati, PhD

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Sacchin Parikh, MD

313-916-2721Sparikh2@hfhs.org

Meghan McCarthy

mmccart8@hfhs.org

Principal Investigator:

Sachin Parikh, MD

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Sameer Jamal, MD

551-996-5870sameer.jamal@hmhn.org

Manuel Castillo, RN

5519962136Manuel.Castillo@hmhn.org

Principal Investigator:

Sameer Jamal, MD

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10019

Contacts

Joslin J Plathottam, MBBS, MPH

631-750-6345JoslinJose.Plathottam@mountsinai.org

Jeffrey Bander, MD, FACC

212-381-0918Jeffrey.bander@mountsinai.org

Principal Investigator:

Johanna Contreras, MD

Moses H. Cone Memorial Hospital

Recruiting

Greensboro, North Carolina, United States, 27401

Contacts

Jennifer Knapp

336-832-3795Jennifer.knapp@conehealth.com

Kimberly Lutterloh

336-832-3748Kimberly.lutterloh@conehealth.com

Principal Investigator:

Daniel Bensimhon, MD

Texas Cardiac Arrhythmia Research Foundation

Recruiting

Austin, Texas, United States, 78705

Contacts

Andrea Natale, MD

512-807-3150tcarfan@gmail.com

Deb Cardinal

dscardinal@austinheartbeat.com

Principal Investigator:

Andrea Natale, MD

South Heart Clinic

Recruiting

Weslaco, Texas, United States, 78596

Contacts

Frank Mazzola, MD

877-426-7457frank.mazzola@southheartclinic.org

Nathalie Guajardo

9564285522Nathalie.guajardo@southheartclinic.org

More Information

Sponsor

Peerbridge Health, Inc

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

  • ECG Patch
  • LVEF
  • Holter
  • ECG Wearable
  • COR
  • Atrial Conduction
  • ECG Biomarker
  • LV Dysfunction
  • SaMD
  • Clinical Decision Support
  • ECG
  • EF Severity
  • Ejection Fraction
  • AI
  • Atrial Enlargement
  • Electrical Remodeling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Peerbridge Health, Inc on 2026-06-01.