ClinicalTrials.gg
CompletedNCT03438799Updated Nov 6, 2026

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

An observational study in Heart Failure, sponsored by Cordio Medical. Completed at 7 sites in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Cordio Medical · Observational

Updated Nov 6, 2026Now CompletedPrimary completion moved+4 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
427
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 182 studies in Heart Failure with a site in Israel — 23 open to participants now, 28 under way, 7 of them phase 3. Heart Failure · Israel.

Enrollment
16th of 46
427 · median 150
Started
2015
with 9 others
Observational
46 of 182
7 open now
Registered
128th of 182
by date
Lead sponsor
5 of 182
Cordio Medical

Among the 182 studies in Heart Failure with a site in Israel, this one is the 16th largest by enrollment of the 46 observational ones, is one of 10 that started in 2015, is one of 46 observational ones, and was the 128th registered.

By phase

182 studies; the count open now beside each. This study's row is marked.

No phase53 · 7 open
Observationalthis study46 · 7 open
Phase 339 · 7 open
Phase 225 · 1 open
Phase 410 · 1 open
Phase 2/34 · 0 open
Phase 13 · 0 open
Phase 1/22 · 0 open

By the year they started

First in 1983; this study’s year is marked. 10 started in 2015.

Size and results

Median enrollment 260 across the 134 interventional studies, 150 across the 46 observational. Of the 116 that completed or were terminated, 43 (37%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 182 studies in Heart Failure with a site in Israel, or all of them as a file.
02

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

03

Conditions studied

  • Heart Failure

Browse trials for

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age > 18 years.
  2. Symptomatic Heart Failure Patient.
  3. The patient is willing to participate as evidenced by signing the written .
  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 device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
427 participants (actual)
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

06

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

07

Study locations

7 sites
  • Barzilai Medical Center
    Ashkelon, Israel
  • Clalit Bat Yam
    Bat Yam, Israel
  • Clalit Be'er Sheva
    Beersheba, Israel
  • Clalit Bet Shemesh
    Bet Shemesh, Israel
  • Hillel Yaffe Medical Center
    Hadera, Israel
  • Galilee Medical Center
    Nahariya, Israel
  • Rabin Medical Center
    Petah Tikva, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2015 to primary completion in Apr 2024, 102 months.

Of 182 industry-sponsored observational studies under Heart Failure, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 57. This study's 102 months is above that.

Counting every sponsor, half of 975 studies reached it within 41 months; a quarter within 23 and three quarters within 89.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 6, 2026: primary completion Apr 2022 → Apr 2024 and completion Apr 2022 → Apr 2024.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Feb 11, 2018
First posted
Feb 20, 2018
StartActual
Oct 20, 2015
Primary completionActual
Apr 2024was Apr 2022
CompletionActual
Apr 2024was Apr 2022
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Status unknown→Completed
changed Nov 6, 2026
Sites
2 sites added, 3 sites removed
Show 2 added (2 Israel)
  • Clalit Be'er Sheva · Beersheba, Israel
  • Rabin Medical Center · Petah Tikva, Israel
Show 3 removed
  • Clalit Be'er Sheva · Be'er Sheva, Israel
  • Shamir Medical Center · Be'er Ya'aqov, Israel
  • Rabin Medical Center · Petah tikva, Israel
Nov 6, 2026
Primary completion
Apr 2022→Apr 2024 (actual)
Nov 6, 2026
Study completion
Apr 2022→Apr 2024 (actual)
Nov 6, 2026
Enrollment
500 (estimated)→427 (actual)
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Status unknown→Completed
    2 sites added, 3 sites removed
    Show 2 added (2 Israel)
    • Clalit Be'er Sheva · Beersheba, Israel
    • Rabin Medical Center · Petah Tikva, Israel
    Show 3 removed
    • Clalit Be'er Sheva · Be'er Sheva, Israel
    • Shamir Medical Center · Be'er Ya'aqov, Israel
    • Rabin Medical Center · Petah tikva, Israel
    Primary completion Apr 2022→Apr 2024 (now actual)
    Study completion Apr 2022→Apr 2024 (now actual)
    Enrollment 500 (estimated)→427 (actual)
    + 3 other changes: verification date, contact details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

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 2024
Completion
Apr 2024
Last update
Nov 6, 2026

Oversight

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

Not currently enrolling

This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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