AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM
NCT ID: NCT06378632
Last Updated: 2025-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2022-02-11
2025-07-15
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Hearo App
No intervention - only data collection
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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
22 Years
ALL
No
Sponsors
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Cordio Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Ronit Haviv, PhD
Role: STUDY_DIRECTOR
Cordio Medical
Locations
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Eastern Shore Research Institute
Fairhope, Alabama, United States
UC San Diego Health
La Jolla, California, United States
VA Loma Linda Healthcare System
Loma Linda, California, United States
VA San Diego
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Kaiser Permanente San Francisco
San Francisco, California, United States
Nature Coast Clinical Research
Crystal River, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Amavita Clinical Research
Miami, Florida, United States
Advance Medical Research Services Corp (AMRS)
Miami, Florida, United States
Baptist Health (Miami Cardiac & Vascular Institute)
Miami, Florida, United States
Comprehensive Medical & Research Center
Plantation, Florida, United States
St. Johns Center for Clinical Research
Saint Augustine, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
West Georgia Cardiology
Carrollton, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
Advocate Illinois Masonic Health Center
Downers Grove, Illinois, United States
Midwest Cardiovascular Center
Naperville, Illinois, United States
Robert J. Dole VA Medical Center
Wichita, Kansas, United States
St. Elizabeth Healthcare
Edgewood, Kentucky, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Cardiovascular Institute of the South
Lafayette, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Nebraska Heart Center
Lincoln, Nebraska, United States
VA Southern Nevada Healthcare System
North Las Vegas, Nevada, United States
Mount Sinai Morningside
New York, New York, United States
The Mount Sinai Hospital
New York, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Mission Hospital
Asheville, North Carolina, United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States
The Lindner Research Center at The Christ Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Rio Grande Regional Hospital
McAllen, Texas, United States
Methodist Hospital of San Antonio
San Antonio, Texas, United States
University Hospital Samson Assuta Ashdod
Ashdod, , Israel
Assuta Be'er Sheva Medical Center
Beersheba, , Israel
Rambam Medical Center
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Galiee Medical Center
Nahariya, , Israel
Tel Aviv Sourasky (Ichilov) Medical Center
Tel Aviv, , Israel
Poriya Medical Center
Tiberias, , Israel
Hospital Universitari Germans Trias i Pujol
Badalona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Sapir Swisa, SC
Role: primary
Alex Demitriev, SC
Role: primary
Ludmila Helmer, SC
Role: primary
Hadas Barda, SC
Role: primary
Etti Lasri Kadosh, SC
Role: primary
Tal Fux, SC
Role: primary
Jannat Mukari, SC
Role: primary
Other Identifiers
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CLN0011 DETECT-HF
Identifier Type: -
Identifier Source: org_study_id
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