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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cordio Medical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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