An INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY to ASSESS the PERFORMANCE of the CORDIO HEARO SYSTEM

Last updated: March 25, 2025
Sponsor: Cordio Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Hyponatremia

Congestive Heart Failure

Treatment

Hearo App

Clinical Study ID

NCT06378632
CLN0011 DETECT-HF
  • Ages > 22
  • All Genders

Study Summary

Study Design:

This is an international, multicenter, observational, non-interventional, prospective, blinded, single-arm, two-period study, to collect patient utterances that will be retrospectively analyzed to determine the sensitivity and UPNR of the HearO system.

Eligibility Criteria

Inclusion

Major Inclusion Criteria:

  1. Age 22 or greater

  2. Diagnosed with Symptomatic Chronic Heart Failure [NYHA II-IVa (ambulatory)]

  3. At least one of the following:

  4. One ADHF hospitalization in the last 12 months

  5. One unplanned IV/SC diuretic administration in the last 6 months

  6. Two unplanned IV/SC diuretic administrations in the last 12 months

  7. NTProBNP >500 pg/ml

  8. Clinically stable HF according to investigator discretion

  9. Willing to participate as evidenced by signing the written informed consent.

Exclusion

Major Exclusion Criteria:

  1. Unable to comply with daily use of the App,

  2. Has had a major cardiovascular event within 3 months prior to enrolment.

  3. Had a Cardiac Resynchronization Therapy Device (CRT) implanted or upgrading ≤ 1month prior to screening visit.

  4. Has estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73.

  5. Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.

  6. Was treated for a significant COPD

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Hearo App
Phase:
Study Start date:
February 11, 2022
Estimated Completion Date:
July 15, 2025

Study Description

Two periods:

Run-In period will be a period in which patients will submit daily recordings, baseline creation

Core period will be a period in which patients will be followed up and will continually submit daily recordings for up-to 24 months per patient or until End-of-Study (EOS), whichever comes first.

Connect with a study center

  • University Hospital Samson Assuta Ashdod

    Ashdod,
    Israel

    Active - Recruiting

  • Assuta Be'er Sheva Medical Center

    Be'er Sheva,
    Israel

    Active - Recruiting

  • Rambam Medical Center

    Haifa,
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem,
    Israel

    Active - Recruiting

  • Galiee Medical Center

    Nahariya,
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky (Ichilov) Medical Center

    Tel Aviv,
    Israel

    Active - Recruiting

  • Poriya Medical Center

    Tiberias,
    Israel

    Active - Recruiting

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916
    Spain

    Active - Recruiting

  • Eastern Shore Research Institute

    Fairhope, Alabama 36532
    United States

    Active - Recruiting

  • UC San Diego Health

    La Jolla, California 92037
    United States

    Active - Recruiting

  • VA Loma Linda Healthcare System

    Loma Linda, California 92357
    United States

    Active - Recruiting

  • VA San Diego

    San Diego, California 92161
    United States

    Active - Recruiting

  • Kaiser Permanente San Francisco

    San Francisco, California 94118
    United States

    Active - Recruiting

  • University of California, San Francisco

    San Francisco, California 94117
    United States

    Active - Recruiting

  • Nature Coast Clinical Research

    Crystal River, Florida 34429
    United States

    Active - Recruiting

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • Advance Medical Research Services Corp (AMRS)

    Miami, Florida 33173
    United States

    Active - Recruiting

  • Amavita Clinical Research

    Miami, Florida 33137
    United States

    Active - Recruiting

  • Baptist Health (Miami Cardiac & Vascular Institute)

    Miami, Florida 33173
    United States

    Active - Recruiting

  • Comprehensive Medical & Research Center

    Plantation, Florida 33317
    United States

    Active - Recruiting

  • St. Johns Center for Clinical Research

    Saint Augustine, Florida 32086
    United States

    Site Not Available

  • St. Johns Center for Clinical Research

    St. Augustine, Florida 32086
    United States

    Active - Recruiting

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • West Georgia Cardiology

    Carrollton, Georgia 30117
    United States

    Active - Recruiting

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois 60657
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Advocate Illinois Masonic Health Center

    Downers Grove, Illinois 60515
    United States

    Active - Recruiting

  • Midwest Cardiovascular Center

    Naperville, Illinois 60540
    United States

    Active - Recruiting

  • Robert J. Dole VA Medical Center

    Wichita, Kansas 67218
    United States

    Active - Recruiting

  • St. Elizabeth Healthcare

    Edgewood, Kentucky 41017
    United States

    Active - Recruiting

  • Cardiovascular Institute of the South

    Houma, Louisiana 70360
    United States

    Active - Recruiting

  • Cardiovascular Institute of the South

    Lafayette, Louisiana 70503
    United States

    Active - Recruiting

  • University Medical Center New Orleans

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

  • Nebraska Heart Center

    Lincoln, Nebraska 68526
    United States

    Active - Recruiting

  • VA Southern Nevada Healthcare System

    North Las Vegas, Nevada 89086
    United States

    Active - Recruiting

  • Mount Sinai Morningside

    New York, New York 10025
    United States

    Active - Recruiting

  • The Mount Sinai Hospital

    New York, New York 10029
    United States

    Active - Recruiting

  • St. Francis Hospital

    Roslyn, New York 11576
    United States

    Active - Recruiting

  • Mission Hospital

    Asheville, North Carolina 28803
    United States

    Active - Recruiting

  • Moses H. Cone Memorial Hospital

    Greensboro, North Carolina 27401
    United States

    Active - Recruiting

  • The Lindner Research Center at The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Rio Grande Regional Hospital

    McAllen, Texas 78503
    United States

    Active - Recruiting

  • Methodist Hospital of San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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