Chronic Heart FailureNCT05876533
R&D Study to Evaluate Cordio's Usability and to Collect Patient Speech Utterances
An observational study of Chronic Heart Failure, run by Cordio Medical at 8 sites in 2 countries.
Trial summary
To determine the usability and technical aspects of Cordio HearO™ Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Cordio HearO
- Type of treatment
- Medical device
- How many people
- 216 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 18 Mar 2022to 15 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult clinical stable patients with NYHA II-IVa (ambulatory)
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.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States5 sites
Lake County Med Grp
Athens, Georgia, 31024
C&R Research Services
Cape Coral, Florida, 33904
C&R Research Services
Miami, Florida, 33176
C&R Research Services
Miami, Florida, 33183
Kurker Family Medicine
South Windsor, Connecticut, 06074
Israel3 sites
Barzilai Medical Center- Cardiology
Ashkelon
Heart Failure Clinic - Clallit Be'er Sheva
Beersheba
Rabin Medical Center - Cardiology- CHF
Petah Tikva, 49100
About this study
Official title: An Observational, Retrospective, Single-arm, Open US and Israel Study , for Usability Assessment and Algorithm, Development of the Cordio HearO™ Systeam
To determine the usability and technical aspects of Cordio HearO™
Read the detailed description
The system (including App and server) will be tested under simulated use conditions with representative users to identify potential changes required to the application user interface, to improve user performance and satisfaction, and to inform future design options.
The recordings data will also be used for algorithm improvement
- Conditions
- Chronic Heart Failure
- Being tested
- Cordio HearO
- Keywords
- CHF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cordio HearODevice
Cordio HearO is a software medical device that remotely monitors Congestive Heart Failure (CHF) patients by detecting changes in the patients' recorded voice relative to a baseline. The system is comprised of a mobile application (or "app") that is deployed on a mobile platform, and a web-based portal that enables caregivers to manage their patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Usability success defined as: 1.Total and individual usability score of ≥3 in the usability questionnaire in ≥80% of the users.
The used scale is: Usability questionnaire for the Cordio HearO™ App. This Usability questionnaire is a subjective evaluation based on Likert score of device user satisfaction.
Maximum value for each item: 5 Minimum value for each item: 1 Higher scores means a better outcome
Measured: 2 years
Patient Usability success defined as: 2. Total Compliance
The total compliance will be determined by the total number of recording days. Success will be considered if total average compliance of 70 % of all days.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start18 Mar 2022
- Primary completion31 Jan 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordio Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronit Haviv, PhD, Study director, Cordio Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876533
- Sponsor's protocol ID
- CLN0016
- Status last verified
- Dec 2024
- First submitted
- 23 Apr 2023
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Retrospective, Single-arm, Open US and Israel Study , for Usability Assessment and Algorithm, Development of the Cordio HearO™ Systeam
- ClinicalTrials.gov ID
- NCT05876533
- Acronym / sponsor ID
- CLN0016
- Conditions
- Chronic Heart Failure
- Keywords
- CHF
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Cordio MedicalIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the usability and technical aspects of Cordio HearO™
Detailed description
The system (including App and server) will be tested under simulated use conditions with representative users to identify potential changes required to the application user interface, to improve user performance and satisfaction, and to inform future design options.
The recordings data will also be used for algorithm improvement
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult clinical stable patients with NYHA II-IVa (ambulatory)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cordio HearOCordio HearO is a software medical device that remotely monitors Congestive Heart Failure (CHF) patients by detecting changes in the patients' recorded voice relative to a baseline. The system is comprised of a mobile application (or "app") that is deployed on a mobile platform, and a web-based portal that enables caregivers to manage their patients | Device | – |
Primary outcome
Patient Usability success defined as: 1.Total and individual usability score of ≥3 in the usability questionnaire in ≥80% of the users.
Time frame: 2 years
The used scale is: Usability questionnaire for the Cordio HearO™ App. This Usability questionnaire is a subjective evaluation based on Likert score of device user satisfaction. Maximum value for each item: 5 Minimum value for each item: 1 Higher scores means a better outcome
Patient Usability success defined as: 2. Total Compliance
Time frame: 2 Years
The total compliance will be determined by the total number of recording days. Success will be considered if total average compliance of 70 % of all days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronit Haviv, PhD study director
Cordio Medical
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure, run by Cordio Medical at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Usability success defined as: 1.Total and individual usability score of ≥3 in the usability questionnaire in ≥80% of the users. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.