TrialPath
← Back to searchRecruiting

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

NCT06378632 · Cordio Medical
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
An International Multi-center Observational, Single-arm, Blinded Study to Assess the Performance of the Cordio HearO System
About this study
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.
Eligibility criteria
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 design
Enrollment target: 500 participants
Age groups: adult, older_adult
Timeline
Starts: 2022-02-11
Estimated completion: 2025-07-15
Last updated: 2025-03-26
Interventions
Device: Hearo App
Primary outcomes
  • Heart Failure Events (HFEs) (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)
Sponsor
Cordio Medical · industry
Contacts & investigators
ContactBill Tobin · contact · billt@ihcresearch.com · (203) 852-8900
InvestigatorRonit Haviv, PhD · study_director, Cordio Medical
All locations (45)
Eastern Shore Research InstituteRecruiting
Fairhope, Alabama, United States
UC San Diego HealthRecruiting
La Jolla, California, United States
VA Loma Linda Healthcare SystemRecruiting
Loma Linda, California, United States
VA San DiegoRecruiting
San Diego, California, United States
University of California, San FranciscoRecruiting
San Francisco, California, United States
Kaiser Permanente San FranciscoRecruiting
San Francisco, California, United States
Nature Coast Clinical ResearchRecruiting
Crystal River, Florida, United States
Jacksonville Center for Clinical ResearchRecruiting
Jacksonville, Florida, United States
Amavita Clinical ResearchRecruiting
Miami, Florida, United States
Advance Medical Research Services Corp (AMRS)Recruiting
Miami, Florida, United States
Baptist Health (Miami Cardiac & Vascular Institute)Recruiting
Miami, Florida, United States
Comprehensive Medical & Research CenterRecruiting
Plantation, Florida, United States
St. Johns Center for Clinical ResearchRecruiting
Saint Augustine, Florida, United States
Tampa General HospitalRecruiting
Tampa, Florida, United States
West Georgia CardiologyRecruiting
Carrollton, Georgia, United States
University of ChicagoRecruiting
Chicago, Illinois, United States
Advocate Illinois Masonic Medical CenterRecruiting
Chicago, Illinois, United States
Advocate Illinois Masonic Health CenterRecruiting
Downers Grove, Illinois, United States
Midwest Cardiovascular CenterRecruiting
Naperville, Illinois, United States
Robert J. Dole VA Medical CenterRecruiting
Wichita, Kansas, United States
St. Elizabeth HealthcareRecruiting
Edgewood, Kentucky, United States
Cardiovascular Institute of the SouthRecruiting
Houma, Louisiana, United States
Cardiovascular Institute of the SouthRecruiting
Lafayette, Louisiana, United States
University Medical Center New OrleansRecruiting
New Orleans, Louisiana, United States
Nebraska Heart CenterRecruiting
Lincoln, Nebraska, United States
VA Southern Nevada Healthcare SystemRecruiting
North Las Vegas, Nevada, United States
Mount Sinai MorningsideRecruiting
New York, New York, United States
The Mount Sinai HospitalRecruiting
New York, New York, United States
St. Francis HospitalRecruiting
Roslyn, New York, United States
Mission HospitalRecruiting
Asheville, North Carolina, United States
Moses H. Cone Memorial HospitalRecruiting
Greensboro, North Carolina, United States
The Lindner Research Center at The Christ HospitalRecruiting
Cincinnati, Ohio, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
The Ohio State UniversityRecruiting
Columbus, Ohio, United States
Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, United States
Rio Grande Regional HospitalRecruiting
McAllen, Texas, United States
Methodist Hospital of San AntonioRecruiting
San Antonio, Texas, United States
University Hospital Samson Assuta AshdodRecruiting
Ashdod, Israel
Assuta Be'er Sheva Medical CenterRecruiting
Beersheba, Israel
Rambam Medical CenterRecruiting
Haifa, Israel
Shaare Zedek Medical CenterRecruiting
Jerusalem, Israel
Galiee Medical CenterRecruiting
Nahariya, Israel
Tel Aviv Sourasky (Ichilov) Medical CenterRecruiting
Tel Aviv, Israel
Poriya Medical CenterRecruiting
Tiberias, Israel
Hospital Universitari Germans Trias i PujolRecruiting
Badalona, Spain
AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM · TrialPath