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

Last updated: April 24, 2021
Sponsor: Cordio Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT03438799
CLN 0011 (CLN0004, CA001)
  • Ages > 18
  • All Genders

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age > 18 years.
  2. Symptomatic Heart Failure Patient.
  3. The patient is willing to participate as evidenced by signing the written informedconsent.
  4. Male or non-pregnant female patient.

Exclusion

Exclusion Criteria:

  1. Subject who, in the Investigator's opinion, unable to comply with the daily use of theApp 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 hasnot completed the primary endpoint or that clinically interferes with the currentstudy endpoints.

Study Design

Total Participants: 500
Study Start date:
October 20, 2015
Estimated Completion Date:
April 30, 2022

Connect with a study center

  • Barzilai Medical Center

    Ashkelon,
    Israel

    Active - Recruiting

  • Clalit Bat Yam

    Bat Yam,
    Israel

    Active - Recruiting

  • Clalit Be'er Sheva

    Be'er Sheva,
    Israel

    Active - Recruiting

  • Shamir Medical Center

    Be'er Ya'aqov, 70300
    Israel

    Active - Recruiting

  • Clalit Bet Shemesh

    Bet Shemesh,
    Israel

    Active - Recruiting

  • Hillel Yaffe Medical Center

    Hadera,
    Israel

    Active - Recruiting

  • Galilee Medical Center

    Nahariya,
    Israel

    Active - Recruiting

  • Rabin Medical Center

    Petah tikva,
    Israel

    Active - Recruiting

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