An INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY to ASSESS the PERFORMANCE of the CORDIO HEARO SYSTEM (DETECT-HF)

March 25, 2025 updated by: Cordio Medical

An International Multi-center Observational, Single-arm, Blinded Study to Assess the Performance of the Cordio HearO System

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Ashdod, Israel
        • Recruiting
        • University Hospital Samson Assuta Ashdod
        • Contact:
          • Sapir Swisa, SC
        • Contact:
          • Alexander Goldman, MD
      • Be'er Sheva, Israel
        • Recruiting
        • Assuta Be'er Sheva Medical Center
        • Contact:
          • Alex Demitriev, SC
        • Contact:
          • Amos Katz, MD
      • Haifa, Israel
        • Recruiting
        • Rambam Medical Center
        • Contact:
          • Ludmila Helmer, SC
          • Phone Number: 972-4-7773475
        • Contact:
          • Oren Caspi, MD
      • Jerusalem, Israel
        • Recruiting
        • Shaare Zedek Medical Center
        • Contact:
          • Hadas Barda, SC
          • Phone Number: 972-2-6666769
        • Contact:
          • Tal Hasin, MD
      • Nahariya, Israel
        • Recruiting
        • Galiee Medical Center
        • Contact:
          • Etti Lasri Kadosh, SC
          • Phone Number: 972-4-9107747
        • Contact:
          • Shaul Atar, MD
      • Tel Aviv, Israel
        • Recruiting
        • Tel Aviv Sourasky (Ichilov) Medical Center
        • Contact:
          • Tal Fux, SC
          • Phone Number: 972-3-6972420
        • Contact:
          • Michal Laufer Perl, MD
      • Tiberias, Israel
        • Recruiting
        • Poriya Medical Center
        • Contact:
          • Jannat Mukari, SC
          • Phone Number: 972-4-6652201
        • Contact:
          • Wadi Kinany, MD
  • Spain
      • Badalona, Spain, 08916
        • Recruiting
        • Hospital Universitari Germans Trias i Pujol
        • Contact:
        • Contact:
          • Antoni Bayes-Genis, MD
  • United States
    • Alabama
      • Fairhope, Alabama, United States, 36532
        • Recruiting
        • Eastern Shore Research Institute
        • Contact:
        • Contact:
          • Michael Pursley, MD
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego Health
        • Contact:
        • Contact:
          • Nicholas Wettersten, MD
      • Loma Linda, California, United States, 92357
        • Recruiting
        • VA Loma Linda Healthcare System
        • Contact:
          • Jay Patel, MD
        • Contact:
      • San Diego, California, United States, 92161
        • Recruiting
        • VA San Diego
        • Contact:
        • Contact:
          • Nancy Gardetto, MD
      • San Francisco, California, United States, 94118
        • Recruiting
        • Kaiser Permanente San Francisco
        • Contact:
        • Contact:
          • Jana Svetlichanaya, MD
      • San Francisco, California, United States, 94117
        • Recruiting
        • University of California, San Francisco
        • Contact:
          • Liviu Klein, MD
        • Contact:
    • Florida
      • Crystal River, Florida, United States, 34429
        • Recruiting
        • Nature Coast Clinical Research
        • Contact:
        • Contact:
          • Susan Pasupuleti, MD
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • Jacksonville Center for Clinical Research
        • Contact:
        • Contact:
          • Michael Koren, MD
      • Miami, Florida, United States, 33137
        • Recruiting
        • Amavita Clinical Research
        • Contact:
        • Contact:
          • Pedro Martinez Clark, MD
      • Miami, Florida, United States, 33173
        • Recruiting
        • Advance Medical Research Services Corp (AMRS)
        • Contact:
        • Contact:
          • Yordan Orive Gomez, MD
      • Miami, Florida, United States, 33173
        • Recruiting
        • Baptist Health (Miami Cardiac & Vascular Institute)
        • Contact:
        • Contact:
          • Sandra Chaparro, MD
      • Plantation, Florida, United States, 33317
        • Recruiting
        • Comprehensive Medical & Research Center
        • Contact:
        • Contact:
          • William Korey, MD
      • St. Augustine, Florida, United States, 32086
        • Recruiting
        • St. Johns Center for Clinical Research
        • Contact:
        • Contact:
          • Ameeth Vedre, MD
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital
        • Contact:
        • Contact:
          • Debbie Hoffman, MD
    • Georgia
      • Carrollton, Georgia, United States, 30117
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Contact:
        • Contact:
          • Gene Kim, MD
      • Chicago, Illinois, United States, 60657
        • Recruiting
        • Advocate Illinois Masonic Medical Center
        • Contact:
        • Contact:
          • Sorin Danciu, MD
      • Downers Grove, Illinois, United States, 60515
        • Recruiting
        • Advocate Illinois Masonic Health Center
        • Contact:
          • Sorin Danciu, MD
        • Contact:
      • Naperville, Illinois, United States, 60540
        • Recruiting
        • Midwest Cardiovascular Center
        • Contact:
        • Contact:
          • Maria Rosa Costanzo, MD
    • Kansas
      • Wichita, Kansas, United States, 67218
        • Recruiting
        • Robert J. Dole VA Medical Center
        • Contact:
        • Contact:
          • Freidy Eid, MD
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Recruiting
        • St. Elizabeth Healthcare
        • Contact:
        • Contact:
          • Haree Vongooru, MD
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Recruiting
        • Cardiovascular Institute of the South
        • Contact:
          • Peter Fail, MD
        • Contact:
      • Lafayette, Louisiana, United States, 70503
        • Recruiting
        • Cardiovascular Institute of the South
        • Contact:
        • Contact:
          • Wade May, MD
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center New Orleans
        • Contact:
        • Contact:
          • Frank Smart, MD
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Recruiting
        • Nebraska Heart Center
        • Contact:
        • Contact:
          • Steven Krueger, MD
    • Nevada
      • North Las Vegas, Nevada, United States, 89086
        • Recruiting
        • VA Southern Nevada Healthcare System
        • Contact:
        • Contact:
          • Marriyam Moten, MD
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • The Mount Sinai Hospital
        • Contact:
        • Contact:
          • Anuradha Lala - Trindade, MD
      • New York, New York, United States, 10025
      • Roslyn, New York, United States, 11576
        • Recruiting
        • St. Francis Hospital
        • Contact:
          • Rita Jermyn, MD
        • Contact:
    • North Carolina
      • Asheville, North Carolina, United States, 28803
      • Greensboro, North Carolina, United States, 27401
        • Recruiting
        • Moses H. Cone Memorial Hospital
        • Contact:
          • Daniel Bensimhon, MD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Cleveland Clinic
        • Contact:
          • W.H. Wilson Tang, MD
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Contact:
          • Rami Kahwash, MD
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • JoAnn Lindenfeld, MD
        • Contact:
    • Texas
      • McAllen, Texas, United States, 78503
        • Recruiting
        • Rio Grande Regional Hospital
        • Contact:
        • Contact:
          • Norman Ramirez, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Methodist Hospital of San Antonio
        • Contact:
          • Sachin Gupta, MD
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Outpatient clinics

Description

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:

    1. One ADHF hospitalization in the last 12 months
    2. One unplanned IV/SC diuretic administration in the last 6 months
    3. Two unplanned IV/SC diuretic administrations in the last 12 months
    4. NTProBNP >500 pg/ml
  4. Clinically stable HF according to investigator discretion
  5. Willing to participate as evidenced by signing the written informed consent.

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 ≤ 1 month 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Failure Events (HFEs)
Time Frame: EOS is defined as when a total of at least 78 first usable and CEC-adjudicated HFEs have occurred or up-to 24 months per patient

Until the end of the study, each participant will be assigned to one of the following event outcomes:

  1. Having at least one protocol-defined Heart Failure Event (HFE) in the CORE period
  2. Having no Heart Failure Event (HFE) during the entire CORE period
EOS is defined as when a total of at least 78 first usable and CEC-adjudicated HFEs have occurred or up-to 24 months per patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cordio Medical

Investigators

  • Study Director: Ronit Haviv, PhD, Cordio Medical

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 Major Dates

Study Start (Actual)

February 11, 2022

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 15, 2025

Study Registration Dates

First Submitted

April 14, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN0011 DETECT-HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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