EarlySense Monitoring Device Evaluation on CHF Patients

This study has been completed.
Sponsor:
Collaborator:
Rambam Health Care Campus
Information provided by:
EarlySense Ltd.
ClinicalTrials.gov Identifier:
NCT00382746
First received: September 28, 2006
Last updated: April 22, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention
Congestive Heart Failure
Device: EarlySense monitoring device

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: EarlySense Monitoring Device Evaluation on CHF Patients

Resource links provided by NLM:


Further study details as provided by EarlySense Ltd.:

Estimated Enrollment: 25
Study Start Date: October 2006
Study Completion Date: March 2008
Estimated Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382746

Locations
Israel
Rambam Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
EarlySense Ltd.
Rambam Health Care Campus
Investigators
Principal Investigator: Shmuel Rispler, M.D. Rambam Health Care Campus
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00382746     History of Changes
Other Study ID Numbers: ES- CI 02
Study First Received: September 28, 2006
Last Updated: April 22, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by EarlySense Ltd.:
Congestive
Heart
Failure
CHF

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014