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

April 24, 2021 updated by: Cordio Medical

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ashkelon, Israel
        • Recruiting
        • Barzilai Medical Center
      • Bat Yam, Israel
        • Recruiting
        • Clalit Bat Yam
      • Be'er Sheva, Israel
        • Recruiting
        • Clalit Be'er Sheva
      • Be'er Ya'aqov, Israel, 70300
        • Recruiting
        • Shamir Medical Center
      • Bet Shemesh, Israel
        • Recruiting
        • Clalit Bet Shemesh
      • Hadera, Israel
        • Recruiting
        • Hillel Yaffe Medical Center
      • Nahariya, Israel
        • Recruiting
        • Galilee Medical Center
      • Petah tikva, Israel
        • Recruiting
        • Rabin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with NYHA 2-3. All patients must meet eligibility criteria.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cordio
Cordio R&D database to develop the Cordio System
Device: Cordio System
App, cloud and web device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability
Time Frame: 2 years
Questionnaires with SUS scale and specific app questions in order to assess the app usability
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
SADE Endpoint
Time Frame: 2 years
Demonstration of the safe use of the device by overall incidence of device related adverse events.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cordio Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2015

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

February 11, 2018

First Submitted That Met QC Criteria

February 17, 2018

First Posted (Actual)

February 20, 2018

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 24, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN 0011 (CLN0004, CA001)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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