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

Cordio Medical

Status: Unknown

Conditions: Heart Failure

Treatments: Device: Cordio System

Study type: Observational

Funder types: Industry

Identifiers

NCT03438799

CLN 0011 (CLN0004, CA001)

Details and patient eligibility

About

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

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

500 participants in 1 patient group

Cordio

Description:

Cordio R&D database to develop the Cordio System

Treatment:

Device: Cordio System