EarlySense Monitoring Device Evaluation on CHF Patients | NCT00382746

Studies
EarlySense Monitoring Device Evaluation on CHF Patients

NCT00382746

Sponsor

EarlySense Ltd.

Status

Withdrawn

Last Update Posted

Jul 19, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Congestive Heart Failure

Interventions

EarlySense monitoring device

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No need

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Nov 2007Actual

Completion Date

Mar 2008Actual

First Submitted Date

Sep 28, 2006

First Submission Date that Met QC Criteria

Sep 28, 2006

First Posted Date

Sep 29, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2016

Last Update Posted Date

Jul 19, 2016Estimated

Name	Class
Rambam Health Care Campus	OTHER

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
EarlySense monitoring device	Device

Measure	Description	Time Frame
CHF		1 month

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shmuel Rispler, M.D.	Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Health Care Campus		Haifa		31096	Israel

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided