A Non-Intervantional Study to Create a Patient Recordings and Clinical Database Using the Cordio System

Cordio Medical1 site in 1 country6 target enrollmentMarch 27, 2019

ConditionsHeart Failure

Overview

Phase: N/A
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Cordio Medical
Enrollment: 6
Locations: 1
Primary Endpoint: Number of CHF patients with and without acute lung accumulation. in R&D Database
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is an observational, non-interventional, prospective, single-arm, open study for database establishment for R&D purposes. The study will be conducted in 1 site in Israel with up to fifty (50) patients. Patients under hemodialysis supervision will be enrolled in the clinical trial. Clinical information for the study will be collected at the hospital and at home. The patient will conduct recordings at home every day.

Registry

clinicaltrials.gov

Start Date

March 27, 2019

End Date

March 8, 2021

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Cordio Medical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients undergoing hemodialysis every 5-10 days in order to balance their volume overload.
•Class C Heart Failure patient with reduced EF CHF (EF\<40%) and NYHA 2-
•Patients with dyspnea clinically related to pulmonary congestion
•Patient with more than 3 months HF disease duration.
•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.
•Patients likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit or baseline functional capacity of NYHA
•Patients with evidence of active Infection.
•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.