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Clinical Trials/NCT03438799
NCT03438799UnknownNot Applicable

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 enrollmentStarted: October 20, 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
500
Locations
8
Primary Endpoint
R&D Database & Efficiency
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

R&D Database & Efficiency

Time Frame: 2 years

Building R\&D recording database and retrospectively Cordio System needs to reach correlation between the system generated alerts to HF exacerbation

Secondary Outcomes

  • Usability(2 years)

Investigators

Sponsor
Cordio Medical
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (8)

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