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

A Multi-Center Observational Study to Collect Information Related to the Clinical Significance and Performance of the Cordio System

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03438799

Enrollment

500

Registered

2018-02-20

Start date

2015-10-20

Completion date

2022-04-30

Last updated

2021-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief 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

Interventions

DEVICECordio System

App, cloud and web device

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age \> 18 years. 2. Symptomatic Heart Failure Patient. 3. The patient is willing to participate as evidenced by signing the written informed consent. 4. Male or non-pregnant female patient.

Exclusion criteria

1. 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). 2. Patient who has had a major cardiovascular event (e.g., myocardial infraction, stroke) within 3 months prior to screening visit. 3. Patient with severe alcohol or drug use. 4. Psychological instability, inappropriate attitude or motivation. 5. Patient with life threatening debilitating disease other than cardiac. 6. 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.

Design outcomes

Primary

Measure	Time frame	Description
R&D Database & Efficiency	2 years	Building R&D recording database and retrospectively Cordio System needs to reach correlation between the system generated alerts to HF exacerbation

Secondary

Measure	Time frame	Description
Usability	2 years	Questionnaires with SUS scale and specific app questions in order to assess the app usability

Other

Measure	Time frame	Description
SADE Endpoint	2 years	Demonstration of the safe use of the device by overall incidence of device related adverse events.

Countries

Israel

Contacts

Primary ContactRonit Haviv, PhD

ronit@cordio-med.com972-3-5467163

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026