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

NCT ID: NCT03438799

Last Updated: 2021-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-20

Study Completion Date

2022-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cordio

Cordio R\&D database to develop the Cordio System

Cordio System

Intervention Type DEVICE

App, cloud and web device

Interventions

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Cordio System

App, cloud and web device

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cordio Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Barzilai Medical Center

Ashkelon, , Israel

Site Status RECRUITING

Clalit Bat Yam

Bat Yam, , Israel

Site Status RECRUITING

Clalit Be'er Sheva

Beersheba, , Israel

Site Status RECRUITING

Clalit Bet Shemesh

Bet Shemesh, , Israel

Site Status RECRUITING

Shamir Medical Center

Be’er Ya‘aqov, , Israel

Site Status RECRUITING

Hillel Yaffe Medical Center

Hadera, , Israel

Site Status RECRUITING

Galilee Medical Center

Nahariya, , Israel

Site Status RECRUITING

Rabin Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Ronit Haviv, PhD

Role: CONTACT

972-3-5467163

Facility Contacts

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Ronit Haviv

Role: primary

+972-3-5467163

Daniel Murninkas, Dr.

Role: primary

058-4753375

Jean-Marc Weinstien, Dr.

Role: primary

052-2707697

Elisha Ouzan, Dr.

Role: primary

050-7874159

Ronit Haviv

Role: primary

+972-3-5467163

Ronit Haviv

Role: primary

+972-3-5467163

Ronit Haviv

Role: primary

+972-3-5467163

Ronit Haviv

Role: primary

+972-3-5467163

Other Identifiers

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CLN 0011 (CLN0004, CA001)

Identifier Type: -

Identifier Source: org_study_id

NCT03720509

Identifier Type: -

Identifier Source: nct_alias

NCT03720535

Identifier Type: -

Identifier Source: nct_alias

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