NCT05876533Active, not recruiting
R&D Study to Evaluate Cordio's Usability and to Collect Patient Speech Utterances
An Observational, Retrospective, Single-arm, Open US and Israel Study , for Usability Assessment and Algorithm, Development of the Cordio HearO™ Systeam
Source: ClinicalTrials.gov · Last updated 31 Dec 2024
Brief summary (registry, in English)
To determine the usability and technical aspects of Cordio HearO™
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 216 (actual)
- First submitted
- 23 Apr 2023
- Start date
- 18 Mar 2022
- Primary completion date
- 31 Jan 2025
- Lead sponsor
- Cordio Medical
- Diseases
- Heart failure
- NCT number
- NCT05876533
What you commit to
- Study type: Observational
- Participants enrolled: 216
- From 18 Mar 2022 to the primary completion date, 31 Jan 2025
- 7 sites in 2 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:
- Adults patients
- 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 administration in the last 12 months
- NTProBNP \>500 pg/ml or BNP\*\> 150 pg/ml at screening visit
- Clinically stable HF
- Willing to participate as evidenced by signing the written informed consent.
- Male or non-pregnant female patient (pre-menopausal women will confirm verbally).
- Major exclusion Criteria:
- Not able to read in Hebrew, Russian, Arabic, English and/or Spanish.
- Unable to comply with daily use of the App
- Major cardiovascular event
- Had a Cardiac Resynchronization Device (CRT) implanted or upgrading ≤ 1 month prior to screening visit.
- Has estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73 meter square (Cockroft-Gault formula).
- Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Barzilai Medical Center- Cardiology Coordinator of this site? Confirm its status | Ashkelon | Israel | Unknown status |
| Heart Failure Clinic - Clallit Be'er Sheva Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| Rabin Medical Center - Cardiology- CHF Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Lake County Med Grp Coordinator of this site? Confirm its status | Athens | United States | Unknown status |
| C&R Research Services Coordinator of this site? Confirm its status | Cape Coral | United States | Unknown status |
| C&R Research Services Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Kurker Family Medicine Coordinator of this site? Confirm its status | South Windsor | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.