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

Heart Failure Clinical Trial

Official title:

A Multi-Center 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: NCT03438799
• Other study ID #: CLN 0011 (CLN0004, CA001)
• Status: Recruiting
• Start date: October 20, 2015
• Est. completion date: April 2022

Study information

• Verified date: April 2021
• 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

Other known NCT identifiers

• NCT03720509
• NCT03720535

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Cordio System
App, cloud and web device

Locations

Country	Name	City	State
Israel	Barzilai Medical Center	Ashkelon
Israel	Clalit Bat Yam	Bat Yam
Israel	Clalit Be'er Sheva	Be'er Sheva
Israel	Shamir Medical Center	Be'er Ya'aqov
Israel	Clalit Bet Shemesh	Bet Shemesh
Israel	Hillel Yaffe Medical Center	Hadera
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	SADE Endpoint	Demonstration of the safe use of the device by overall incidence of device related adverse events.	2 years
Primary	R&D Database & Efficiency	Building R&D recording database and retrospectively Cordio System needs to reach correlation between the system generated alerts to HF exacerbation	2 years
Secondary	Usability	Questionnaires with SUS scale and specific app questions in order to assess the app usability	2 years