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NCT06378632Recruiting

AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM

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

Source: ClinicalTrials.gov · Last updated 26 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
500 (estimated)
First submitted
14 Apr 2024
Start date
11 Feb 2022
Primary completion date
1 Jul 2025
Lead sponsor
Cordio Medical
NCT number
NCT06378632

What you commit to

  • Study type: Observational
  • Planned participants: 500
  • From 11 Feb 2022 to the primary completion date, 1 Jul 2025
  • 45 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • Major Inclusion Criteria:
  • Age 22 or greater
  • Diagnosed with Symptomatic Chronic Heart Failure \[NYHA II-IVa (ambulatory)\]
  • At least one of the following:
    • One ADHF hospitalization in the last 12 months
    • One unplanned IV/SC diuretic administration in the last 6 months
    • Two unplanned IV/SC diuretic administrations in the last 12 months
    • NTProBNP \>500 pg/ml
  • Clinically stable HF according to investigator discretion
  • Willing to participate as evidenced by signing the written informed consent.
    • Major Exclusion Criteria:
  • Unable to comply with daily use of the App,
  • Has had a major cardiovascular event within 3 months prior to enrolment.
  • Had a Cardiac Resynchronization Therapy Device (CRT) implanted or upgrading ≤ 1 month prior to screening visit.
  • Has estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73.
  • Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.
  • Was treated for a significant COPD

Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (45)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitari Germans Trias i Pujol
Coordinator of this site? Confirm its status
BadalonaSpainRecruiting
University Hospital Samson Assuta Ashdod
Coordinator of this site? Confirm its status
AshdodIsraelRecruiting
Assuta Be'er Sheva Medical Center
Coordinator of this site? Confirm its status
BeershebaIsraelRecruiting
Rambam Medical Center
Coordinator of this site? Confirm its status
HaifaIsraelRecruiting
Shaare Zedek Medical Center
Coordinator of this site? Confirm its status
JerusalemIsraelRecruiting
Galiee Medical Center
Coordinator of this site? Confirm its status
NahariyaIsraelRecruiting
Tel Aviv Sourasky (Ichilov) Medical Center
Coordinator of this site? Confirm its status
Tel AvivIsraelRecruiting
Poriya Medical Center
Coordinator of this site? Confirm its status
TiberiasIsraelRecruiting
Mission Hospital
Coordinator of this site? Confirm its status
AshevilleUnited StatesRecruiting
West Georgia Cardiology
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CarrolltonUnited StatesRecruiting
University of Chicago
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ChicagoUnited StatesRecruiting
Advocate Illinois Masonic Medical Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
The Lindner Research Center at the Christ Hospital
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CincinnatiUnited StatesRecruiting
Cleveland Clinic
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ClevelandUnited StatesRecruiting
The Ohio State University
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ColumbusUnited StatesRecruiting
Nature Coast Clinical Research
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Crystal RiverUnited StatesRecruiting
Advocate Illinois Masonic Health Center
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Downers GroveUnited StatesRecruiting
St. Elizabeth Healthcare
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EdgewoodUnited StatesRecruiting
Eastern Shore Research Institute
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FairhopeUnited StatesRecruiting
Moses H Cone Memorial Hospital
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GreensboroUnited StatesRecruiting
Cardiovascular Institute of the South
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HoumaUnited StatesRecruiting
Jacksonville Center for Clinical Research
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JacksonvilleUnited StatesRecruiting
Cardiovascular Institute of the South
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LafayetteUnited StatesRecruiting
UC San Diego Health
Coordinator of this site? Confirm its status
La JollaUnited StatesRecruiting
Nebraska Heart Center
Coordinator of this site? Confirm its status
LincolnUnited StatesRecruiting
VA Loma Linda Healthcare System
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Loma LindaUnited StatesRecruiting
Rio Grande Regional Hospital
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McAllenUnited StatesRecruiting
Advance Medical Research Services Corp (AMRS)
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MiamiUnited StatesRecruiting
Amavita Clinical Research
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MiamiUnited StatesRecruiting
Baptist Health Miami Cardiac & Vascular Institute
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MiamiUnited StatesRecruiting
Midwest Cardiovascular Center
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NapervilleUnited StatesRecruiting
Vanderbilt University Medical Center
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NashvilleUnited StatesRecruiting
University Medical Center New Orleans
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New OrleansUnited StatesRecruiting
The Mount Sinai Hospital
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New YorkUnited StatesRecruiting
Mount Sinai Morningside
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New YorkUnited StatesRecruiting
VA Southern Nevada Healthcare System
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North Las VegasUnited StatesRecruiting
Comprehensive Medical & Research Center
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PlantationUnited StatesRecruiting
St. Francis Hospital
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RoslynUnited StatesRecruiting
St. Johns Center for Clinical Research
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Saint AugustineUnited StatesRecruiting
Methodist Hospital of San Antonio
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San AntonioUnited StatesRecruiting
VA San Diego
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San DiegoUnited StatesRecruiting
Kaiser Permanente-San Francisco
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San FranciscoUnited StatesRecruiting
University of California San Francisco
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San FranciscoUnited StatesRecruiting
Tampa General Hospital
Coordinator of this site? Confirm its status
TampaUnited StatesRecruiting
Robert J Dole VA Medical Center
Coordinator of this site? Confirm its status
WichitaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.