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Search / Trial NCT06699056

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

Launched by PEERBRIDGE HEALTH, INC · Nov 18, 2024

Trial Information

Current as of June 23, 2025

Recruiting

Keywords

Ecg Patch Lvef Holter Ecg Wearable Cor Atrial Conduction Ecg Biomarker Lv Dysfunction Sa Md Clinical Decision Support Ecg Ef Severity Ejection Fraction Ai Atrial Enlargement Electrical Remodeling

ClinConnect Summary

This clinical trial is studying a new artificial intelligence (AI) tool that helps doctors assess how well the heart is pumping blood, specifically looking at a measurement called ejection fraction (EF). The trial uses a wearable device called the Peerbridge COR® ECG Monitor, which can be worn like a patch during daily activities. Participants will wear this monitor for five minutes while sitting comfortably, and the AI will analyze the heart's electrical signals to estimate the EF. The results from this AI tool will be compared to traditional heart imaging tests to see how accurately it can measure EF severity.

To be eligible for the study, participants must be at least 18 years old and able to wear the monitor. However, individuals who are on certain types of life-support treatments, or who have specific health issues that might make it unsafe to participate, will not be included. Those who decide to join the trial can expect to wear the monitor and provide information about their heart health, contributing to important research that could improve heart assessments in the future.

Gender

ALL

Eligibility criteria

  • 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

About Peerbridge Health, Inc

Peerbridge Health, Inc. is a forward-thinking clinical trial sponsor dedicated to advancing healthcare through innovative research and technology. With a focus on enhancing patient outcomes, the company specializes in the development and management of clinical trials that leverage cutting-edge methodologies and data analytics. Peerbridge Health collaborates with healthcare providers, researchers, and regulatory bodies to streamline trial processes and ensure compliance, ultimately aiming to bring effective therapies to market faster. Committed to transparency and patient-centric approaches, Peerbridge Health is at the forefront of transforming clinical research into actionable healthcare solutions.

Locations

Detroit, Michigan, United States

Hackensack, New Jersey, United States

Greensboro, North Carolina, United States

Austin, Texas, United States

Orange, California, United States

New York, New York, United States

Melbourne, Florida, United States

Weslaco, Texas, United States

Patients applied

0 patients applied

Trial Officials

Andrea Natale, MD

Principal Investigator

Texas Cardiac Arrhythmia Research Foundation

Johanna P Contreras, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Sachin Parikh, MD

Principal Investigator

Henry Ford Hospital

Brian Kolski, MD

Principal Investigator

Orange County Heart Institute

Daniel Bensimhon, MD

Principal Investigator

Moses H. Cone Memorial Hospital

Sandeep Gulati, PhD

Principal Investigator

Peerbridge Health, Inc

Frank Mazzola, MD

Principal Investigator

South Heart Clinic

Sameer Jamal, MD

Principal Investigator

Hackensack Meridian Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported