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

Cordio Medical8 sites in 1 country500 target enrollmentOctober 20, 2015

ConditionsHeart Failure

Overview

Phase: N/A
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Cordio Medical
Enrollment: 500
Locations: 8
Primary Endpoint: R&D Database & Efficiency
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 20, 2015

End Date

April 2022

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Cordio Medical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age \> 18 years.
•Symptomatic Heart Failure Patient.
•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.
•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.