EarlySense Monitoring Device Evaluation on CHF Patients

NCT ID: NCT00382746

Last Updated: 2016-07-19

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-03-31

Brief Summary

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CHF patients will be monitored using EarlySense ES-16 device and will simultaneously fill diaries and log their weight daily. The data collected and analyzed by the ES-16 device will be correlated with the CHF status data.

Detailed Description

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Conditions

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Congestive Heart Failure

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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EarlySense monitoring device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age over 45 years old
* CHF class II or III with LVEF\<40%
* Hospitalized at least once for CHF deterioration over previous 12 month period
* Able and willing to cooperate with this trial for at least a 3 month period
* Home close to participating center

Exclusion Criteria

* Recent (within 3 month) admission to ICU or CC-ICU due to severe CHF episode requiring artificial ventilation
* Asthma or COPD
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role collaborator

EarlySense Ltd.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Shmuel Rispler, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam Health Care Campus

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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ES- CI 02

Identifier Type: -

Identifier Source: org_study_id

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