RECRUITING

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

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Conditions

Ventricular Ejection FractionLVFLV DysfunctionAtrial EnlargementConduction DefectHeart FailureValvular Heart DiseaseIschemic Heart DiseaseCardiotoxicityMyocardial InfarctionDilated CardiomyopathyHFrEF - Heart Failure with Reduced Ejection FractionHFpEF - Heart Failure with Preserved Ejection FractionSyncopeRemodeling, CardiacECG PatchLVEFHolterECG WearableCORAtrial ConductionECG BiomarkerSaMDClinical Decision SupportECGEF SeverityEjection FractionAIElectrical Remodeling

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-21
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06699056

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Able and eligible to wear a Holter monitor
  1. * Receiving mechanical respiratory or circulatory support, or renal support therapy, at the time of screening or during Visit #1
  2. * Any condition that, in the investigator's opinion, could interfere with compliance with the study protocol or pose a safety risk to the participant
  3. * History of poor tolerance or severe skin reactions to ECG adhesive materials

Contacts and Locations

Study Contact

Sandeep Gulati, PhD
CONTACT
8182162958
s.gulati@peerbridgehealth.com
Chris Darland, MBA
CONTACT
814-572-7138
c.darland@peerbridgehealth.com

Principal Investigator

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

Study Locations (Sites)

Orange County Heart Institute
Orange, California, 92868
United States
Peerbridge Health
Melbourne, Florida, 32935
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Mount Sinai Hospital
New York, New York, 10019
United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401
United States
South Heart Clinic
Weslaco, Texas, 78596
United States

Collaborators and Investigators

Sponsor: Peerbridge Health, Inc

  • 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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-21
Study Completion Date2025-09

Study Record Updates

Study Start Date2024-11-21
Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

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