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

• Conditions: Heart Failure
• Interventions: Device: Cordio System

• Registration Number: NCT03438799
• Lead Sponsor: Cordio Medical

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-20
• Study First Submitted: 2018-02-11
• Study First Submitted QC: 2018-02-17
• Study First Posted: 2018-02-20
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-24
• Last Update Posted: 2021-04-27
• Primary Completion: 2022-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cordio	Cordio System	Cordio R\&D database to develop the Cordio System

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Usability	2 years	Questionnaires with SUS scale and specific app questions in order to assess the app usability

Trial Locations

Locations (8)

Clalit Bat Yam; 🇮🇱 Bat Yam, Israel

Shamir Medical Center; 🇮🇱 Be'er Ya'aqov, Israel

Clalit Bet Shemesh; 🇮🇱 Bet Shemesh, Israel

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel

Rabin Medical Center; 🇮🇱 Petah tikva, Israel

Galilee Medical Center; 🇮🇱 Nahariya, Israel

Barzilai Medical Center; 🇮🇱 Ashkelon, Israel

Clalit Be'er Sheva; 🇮🇱 Be'er Sheva, Israel