Trials Sponsors Conditions Drugs Pricing

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 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age22 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

Adults patients

Sponsors & Collaborators

Cordio Medical
Industrylead

Study Sites (8)

Kurker Family Medicine

South Windsor, Connecticut, 06074, United States

C&R Research Services

Cape Coral, Florida, 33904, United States

C&R Research Services

Miami, Florida, 33176, United States

C&R Research Services

Miami, Florida, 33183, United States

Lake County Med Grp

Athens, Georgia, 31024, United States

Barzilai Medical Center- Cardiology

Ashkelon, Israel

Heart Failure Clinic - Clallit Be'er Sheva

Beersheba, Israel

Study Officials

Ronit Haviv, PhD
Cordio Medical
STUDY DIRECTOR

Enrollment

216 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations