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
- Diseases
- Heart failure
- 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
Sites (45)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| University Hospital Samson Assuta Ashdod Coordinator of this site? Confirm its status | Ashdod | Israel | Recruiting |
| Assuta Be'er Sheva Medical Center Coordinator of this site? Confirm its status | Beersheba | Israel | Recruiting |
| Rambam Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Galiee Medical Center Coordinator of this site? Confirm its status | Nahariya | Israel | Recruiting |
| Tel Aviv Sourasky (Ichilov) Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| Poriya Medical Center Coordinator of this site? Confirm its status | Tiberias | Israel | Recruiting |
| Mission Hospital Coordinator of this site? Confirm its status | Asheville | United States | Recruiting |
| West Georgia Cardiology Coordinator of this site? Confirm its status | Carrollton | United States | Recruiting |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Advocate Illinois Masonic Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| The Lindner Research Center at the Christ Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Nature Coast Clinical Research Coordinator of this site? Confirm its status | Crystal River | United States | Recruiting |
| Advocate Illinois Masonic Health Center Coordinator of this site? Confirm its status | Downers Grove | United States | Recruiting |
| St. Elizabeth Healthcare Coordinator of this site? Confirm its status | Edgewood | United States | Recruiting |
| Eastern Shore Research Institute Coordinator of this site? Confirm its status | Fairhope | United States | Recruiting |
| Moses H Cone Memorial Hospital Coordinator of this site? Confirm its status | Greensboro | United States | Recruiting |
| Cardiovascular Institute of the South Coordinator of this site? Confirm its status | Houma | United States | Recruiting |
| Jacksonville Center for Clinical Research Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Cardiovascular Institute of the South Coordinator of this site? Confirm its status | Lafayette | United States | Recruiting |
| UC San Diego Health Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| Nebraska Heart Center Coordinator of this site? Confirm its status | Lincoln | United States | Recruiting |
| VA Loma Linda Healthcare System Coordinator of this site? Confirm its status | Loma Linda | United States | Recruiting |
| Rio Grande Regional Hospital Coordinator of this site? Confirm its status | McAllen | United States | Recruiting |
| Advance Medical Research Services Corp (AMRS) Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Amavita Clinical Research Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Baptist Health Miami Cardiac & Vascular Institute Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Midwest Cardiovascular Center Coordinator of this site? Confirm its status | Naperville | United States | Recruiting |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| University Medical Center New Orleans Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| The Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Mount Sinai Morningside Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| VA Southern Nevada Healthcare System Coordinator of this site? Confirm its status | North Las Vegas | United States | Recruiting |
| Comprehensive Medical & Research Center Coordinator of this site? Confirm its status | Plantation | United States | Recruiting |
| St. Francis Hospital Coordinator of this site? Confirm its status | Roslyn | United States | Recruiting |
| St. Johns Center for Clinical Research Coordinator of this site? Confirm its status | Saint Augustine | United States | Recruiting |
| Methodist Hospital of San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| VA San Diego Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| Kaiser Permanente-San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Tampa General Hospital Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Robert J Dole VA Medical Center Coordinator of this site? Confirm its status | Wichita | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.