EarlySense Monitoring Device Evaluation on CHF Patients

Congestive Heart Failure Clinical Trial

Official title:

EarlySense Monitoring Device Evaluation on CHF Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00382746
• Other study ID #: ES- CI 02
• Status: Withdrawn
• Phase: N/A
• First received: September 28, 2006
• Last updated: July 17, 2016
• Start date: October 2006
• Est. completion date: March 2008

Study information

• Verified date: April 2008
• Source: EarlySense Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• EarlySense monitoring device

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
EarlySense Ltd.	Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CHF		1 month	No