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

NCT05876533 | Active Not Recruiting FDA Device

• 1 other identifier: CLN0016
• Study Type: observational
• Target: 216
• Locations: 2 countries
• Sites: 8

Brief Summary

To determine the usability and technical aspects of Cordio HearO™

Conditions

Chronic Heart Failure

Keywords

CHF

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Cordio HearO DEVICE

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

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cordio Medical: lead

Study Sites (8)

Kurker Family Medicine

South Windsor, Connecticut, 06074, United States

Location

C&R Research Services

Cape Coral, Florida, 33904, United States

Location

C&R Research Services

Miami, Florida, 33176, United States

Location

C&R Research Services

Miami, Florida, 33183, United States

Location

Lake County Med Grp

Athens, Georgia, 31024, United States

Location

Barzilai Medical Center- Cardiology

Ashkelon, Israel

Location

Heart Failure Clinic - Clallit Be'er Sheva

Beersheba, Israel

Location

Rabin Medical Center - Cardiology- CHF

Petah Tikva, 49100, Israel

Location

Study Officials

• Ronit Haviv, PhD

  Cordio Medical

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: May 25, 2023
• Study Start: March 18, 2022
• Primary Completion: January 31, 2025
• Study Completion: March 15, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-12

Locations

US (5); IL (3)