COMMUNITY STUDY- A Study to Collect Information Related to the Cordio System

Heart Failure Clinical Trial

Official title:

An Observational Study to Collect Information Related to the Clinical Significance and Performance of the Cordio System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03720535
• Other study ID #: CLN0011
• Status: Recruiting
• Start date: February 11, 2019
• Est. completion date: February 2022

Study information

• Verified date: April 2020
• Source: Cordio Medical
• Contact: Ronit Haviv, PhD
• Phone: 972-3-5467163
• Email: ronit[@]cordio-med.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a multi-center, observational, non-interventional, prospective, Single-arm, open study for database establishment for R&D purposes. R&D data will be analyzed retrospectively in order to validate algorithm efficacy. The study will be conducted in the following settings: outpatinets clinics

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Symptomatic Heart Failure Patient.
• Patient with reduced or preserved EF CHF.
• Patient with more than 3 months HF disease duration.
• Patient who passes the "App usage" screening questionnaire (see Appendix B)
• The patient is willing to participate as evidenced by signing the written informed consent.
• Male or non pregnant female patient

Exclusion Criteria:

• Subject who, in the Investigator's opinion, unable to comply with the daily use of the App due to mental disorders (e.g., depression, dementia).
• Patient who has had a major cardiovascular event (e.g., myocardial infraction, stroke) within 3 months prior to screening visit.
• Subject with known coagulation disorders.
• Subject with evidence of active Infection.
• Patient with severe alcohol or drug use.
• Psychological instability, inappropriate attitude or motivation.
• Patient with life threatening debilitating disease other than cardiac.
• Subject currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Cordio Medical
App used for recording, no medical intervention in the patient regular care

Locations

Country	Name	City	State
Israel	Barzilai Medical Center	Ashkelon
Israel	Shamir Medical Center	Be'er Ya'aqov
Israel	Galilee Medical Center	Nahariya
Israel	Rabin Medical Center	Petah tikva

Sponsors (1)

Lead Sponsor	Collaborator
Cordio Medical

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety- Adverse Events	Demonstration of the safe use of the device by means of analysis of overall incidence and severity of device related adverse events.	Throughout Study, 1-2 years per patient
Primary	R&D Database & Efficiency- voice signal analysis	Building R&D recording database and retrospectively Cordio System needs to reach correlation between the system generated alerts (using voice signal analysis- Hz) to HF deterioration	throughout study, 1-2 years per patient
Secondary	Usability- SUS	SUS scale in order to assess the app usability. SUS scale is in the range of 0-100 when higher results are better.	throughout study, 1-2 years per patient