AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM
Recruiting · NCT06378632 · Observational (researchers observe without assigning treatment) · Lead sponsor: Cordio Medical
View the official record on ClinicalTrials.gov →Interventions studied
Hearo App
What this trial is about
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.
Who can take part
Age range
22 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
45 locations listed across 15 US states.
- 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
- Hospital Universitari Germans Trias i Pujol - Badalona, Spain
- 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