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A Study to Collect Information for the Cordio System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438799
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
Cordio Medical

Brief 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: hospital (admission due to CHF exacerbation), CHF clinic and at home.


Condition or disease Intervention/treatment
Heart Failure Device: Cordio System

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-Center Observational Study to Collect Information Related to the Clinical Significance and Performance of the Cordio System
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Usability [ Time Frame: 2 years ]
    Questionnaires with SUS scale and specific app questions in order to assess the app usability


Other Outcome Measures:
  1. SADE Endpoint [ Time Frame: 2 years ]
    Demonstration of the safe use of the device by overall incidence of device related adverse events.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with NYHA 2-3. All patients must meet eligibility criteria.
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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438799


Contacts
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Contact: Orit Ronen, MSc 972-3-5467159 orit@cordio-med.com

Locations
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Israel
Clalit Bat Yam Recruiting
Bat Yam, Israel
Contact: Daniel Murninkas, Dr.    058-4753375    DANIELMU@clalit.org.il   
Clalit Be'er Sheva Recruiting
Be'er Sheva, Israel
Contact: Jean-Marc Weinstien, Dr.    052-2707697    jmwein@bgu.ac.il   
Clalit Bet Shemesh Recruiting
Bet Shemesh, Israel
Contact: Elisha Ouzan, Dr.    050-7874159    elisha_ouzan@yahoo.com   
Sponsors and Collaborators
Cordio Medical
Investigators
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Principal Investigator: Zaza Iakobishvili, Dr. Clalit Center
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Responsible Party: Cordio Medical
ClinicalTrials.gov Identifier: NCT03438799    
Other Study ID Numbers: CLN0004
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases