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

To determine the usability and technical aspects of Cordio HearO™

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Device: 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 Type: Observational
• Enrollment (Actual): 216

Contacts and Locations

Study Locations

• Israel
  • Ashkelon, Israel
    • Barzilai Medical Center- Cardiology
  • Be'er Sheva, Israel
    • Heart Failure Clinic - Clallit Be'er Sheva
  • Petah tikva, Israel, 49100
    • Rabin Medical Center - Cardiology- CHF
• United States
  • Connecticut
    • South Windsor, Connecticut, United States, 06074
      • Kurker Family Medicine
  • Florida
    • Cape Coral, Florida, United States, 33904
      • C&R Research Services
    • Miami, Florida, United States, 33176
      • C&R Research Services
    • Miami, Florida, United States, 33183
      • C&R Research Services
  • Georgia
    • Athens, Georgia, United States, 31024
      • Lake County Med Grp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult clinical stable patients with NYHA II-IVa (ambulatory)

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Cordio Medical
• Investigators: Study Director: Ronit Haviv, PhD, Cordio Medical

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2022
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: April 23, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: CHF
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: CLN0016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No