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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014