CClinicalTrials.gg
Status unknownNCT03438799Updated Apr 27, 2021

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

An observational study in Heart Failure, sponsored by Cordio Medical. Status unknown at 8 sites in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-27.

Sponsored by Cordio Medical · Observational

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
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Study 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

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Conditions studied

  • Heart Failure

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cordio

    Cordio R\&D database to develop the Cordio System

    Device: Cordio System

Interventions

  • DeviceCordio System

    App, cloud and web device

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What researchers measure

Primary outcomes

  1. R&D Database & Efficiency

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

    Time frame: 2 years

Secondary outcomes

  1. Usability

    Questionnaires with SUS scale and specific app questions in order to assess the app usability

    Time frame: 2 years

Other outcomes

  1. SADE Endpoint

    Demonstration of the safe use of the device by overall incidence of device related adverse events.

    Time frame: 2 years

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Study locations

8 of 8 sites recruiting
  • Barzilai Medical Center
    Ashkelon, Israel
    • Ronit Haviv · Contact · ronit@cordio-med.com · +972-3-5467163
    • Chaim Yosefy, Prof. · Principal investigator
    Recruiting
  • Clalit Bat Yam
    Bat Yam, Israel
    Recruiting
  • Clalit Be'er Sheva
    Be'er Sheva, Israel
    Recruiting
  • Shamir Medical Center
    Be'er Ya'aqov, 70300, Israel
    • Ronit Haviv · Contact · ronit@cordio-med.com · +972-3-5467163
    • Gil Moravsky, Dr. · Principal investigator
    Recruiting
  • Clalit Bet Shemesh
    Bet Shemesh, Israel
    Recruiting
  • Hillel Yaffe Medical Center
    Hadera, Israel
    • Ronit Haviv · Contact · ronit@cordio-med.com · +972-3-5467163
    • Michael Kleiner Schochat, Prof. · Principal investigator
    Recruiting
  • Galilee Medical Center
    Nahariya, Israel
    • Ronit Haviv · Contact · ronit@cordio-med.com · +972-3-5467163
    • Robert Dragu, Dr. · Principal investigator
    Recruiting
  • Rabin Medical Center
    Petah tikva, Israel
    • Ronit Haviv · Contact · ronit@cordio-med.com · +972-3-5467163
    • Tuvia Ben Gal, Dr. · Principal investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03438799
Lead sponsor
Cordio Medical
Responsible party
Sponsor
First posted
Feb 20, 2018
Start date
Oct 20, 2015
Primary completion
Apr 2022 (estimated)
Completion
Apr 2022 (estimated)
Last update
Apr 27, 2021

Study contacts

Ronit Haviv, PhD
Contact
ronit@cordio-med.com
972-3-5467163

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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