Enrollment on hold
A Multi-Center Observational Study to Collect Information Related to the Clinical Significance and Performance of the Cordio System
NCT No.: NCT03438799
Study Type: Other Observational Study with Direct Patient Contact
Phase:
Region: California - Northern
Acronym: CLN0011 (C
Official Title
A Multi-Center Observational Study to Collect Information Related to the Clinical Significance and Performance of the Cordio System
Purpose
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
Additional Principal Investigator for this trial: Andrew Ambrosy, San Francisco, CA.
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.
|
Keywords and/or Specific Medical Conditions
Sponsors
|