R&D Study to Evaluate Cordio's Usability and to Collect Patient Speech Utterances

Chronic Heart Failure Clinical Trial

Official title:

An Observational, Retrospective, Single-arm, Open US and Israel Study , for Usability Assessment and Algorithm, Development of the Cordio HearO™ Systeam

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05876533
• Other study ID #: CLN0016
• Status: Recruiting
• Start date: March 18, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: January 2023
• Source: Cordio Medical
• Contact: Moran Elpaz
• Phone: +972-3-5467163
• Email: Moran[@]cordio-med.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To determine the usability and technical aspects of Cordio HearO™

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Major inclusion Criteria:

1. Adults patients

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 administration in the last 12 months

4. NTProBNP >500 pg/ml or BNP*> 150 pg/ml at screening visit

4. Clinically stable HF

5. Willing to participate as evidenced by signing the written informed consent.

6. Male or non-pregnant female patient (pre-menopausal women will confirm verbally).

Major exclusion Criteria:

1. Not able to read in Hebrew, Russian, Arabic, English and/or Spanish.

2. Unable to comply with daily use of the App

3. Major cardiovascular event

4. Had a Cardiac Resynchronization Device (CRT) implanted or upgrading = 1 month prior to screening visit.

5. Has estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73 meter square (Cockroft-Gault formula).

6. Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Device:
• Cordio HearO
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

Locations

Country	Name	City	State
Israel	Barzilai Medical Center- Cardiology	Ashkelon
Israel	Heart Failure Clinic - Clallit Be'er Sheva	Be'er Sheva
Israel	Rabin Medical Center - Cardiology- CHF	Petah tikva
United States	Lake County Med Grp	Athens	Georgia
United States	C&R Research Services	Cape Coral	Florida
United States	C&R Research Services	Miami	Florida
United States	C&R Research Services	Miami	Florida
United States	Kurker Family Medicine	South Windsor	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Cordio Medical

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years
Primary	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.	2 Years