Heart FailureNCT03438799
COMMUNITY STUDY- A Study to Collect Information for the Cordio System
An observational study of Heart Failure, run by Cordio Medical at 8 sites in Israel.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cordio System
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 8 sitesIsrael
- Study dates
- 20 Oct 2015to Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with NYHA 2-3. All patients must meet eligibility criteria.
Who may be able to join
- Age > 18 years.
- Symptomatic Heart Failure Patient.
- The patient is willing to participate as evidenced by signing the written informed consent.
- Male or non-pregnant female patient.
Who cannot join
- 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.
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Israel8 sites, 8 recruiting
- Recruiting
Barzilai Medical Center
Ashkelon
Ronit Haviv, +972-3-5467163, ronit@cordio-med.com
Chaim Yosefy, Prof.
- Recruiting
Clalit Bat Yam
Bat Yam
Daniel Murninkas, Dr., 058-4753375, DANIELMU@clalit.org.il
- Recruiting
Shamir Medical Center
Be’er Ya‘aqov, 70300
Ronit Haviv, +972-3-5467163, ronit@cordio-med.com
Gil Moravsky, Dr.
- Recruiting
Clalit Be'er Sheva
Beersheba
Jean-Marc Weinstien, Dr., 052-2707697, jmwein@bgu.ac.il
- Recruiting
Clalit Bet Shemesh
Bet Shemesh
Elisha Ouzan, Dr., 050-7874159, elisha_ouzan@yahoo.com
- Recruiting
Hillel Yaffe Medical Center
Hadera
Ronit Haviv, +972-3-5467163, ronit@cordio-med.com
Michael Kleiner Schochat, Prof.
- Recruiting
Galilee Medical Center
Nahariya
Ronit Haviv, +972-3-5467163, ronit@cordio-med.com
Robert Dragu, Dr.
- Recruiting
Rabin Medical Center
Petah Tikva
Ronit Haviv, +972-3-5467163, ronit@cordio-med.com
Tuvia Ben Gal, Dr.
About this study
Official title: 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
- Conditions
- Heart Failure
- Being tested
- Cordio System
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cordio SystemDevice
App, cloud and web device
| Study group | Role | What they receive |
|---|---|---|
| Cordio | Cordio R\&D database to develop the Cordio System Receives: Device: Cordio System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (1)
Usability
Questionnaires with SUS scale and specific app questions in order to assess the app usability
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start20 Oct 2015
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cordio Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438799
- Sponsor's protocol ID
- CLN 0011 (CLN0004, CA001)
- Status last verified
- Apr 2021
- First submitted
- 11 Feb 2018
- Last updated
- 27 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Observational Study to Collect Information Related to the Clinical Significance and Performance of the Cordio System
- ClinicalTrials.gov ID
- NCT03438799
- Acronym / sponsor ID
- CLN 0011 (CLN0004, CA001)
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cordio MedicalIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2015 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cordio | – | Device: Cordio SystemCordio R\&D database to develop the Cordio System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with NYHA 2-3. All patients must meet eligibility criteria.
Key inclusion criteria (4 listed)
- Age > 18 years.
- Symptomatic Heart Failure Patient.
- The patient is willing to participate as evidenced by signing the written informed consent.
- Male or non-pregnant female patient.
Key exclusion criteria (6 listed)
- 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.
- Patient with severe alcohol or drug use.
- Psychological instability, inappropriate attitude or motivation.
- Patient with life threatening debilitating disease other than cardiac.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cordio SystemApp, cloud and web device | Device | Cordio |
Primary outcome
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
1 secondary outcome
Usability
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Cordio Medical at 8 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronit Haviv, PhD (972-3-5467163, ronit@cordio-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R&D Database & Efficiency (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.