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EarlySense Monitoring Device Evaluation on CHF Patients

This study has been withdrawn prior to enrollment.
(No need)
Rambam Health Care Campus
Information provided by:
EarlySense Ltd. Identifier:
First received: September 28, 2006
Last updated: July 17, 2016
Last verified: April 2008
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

Further study details as provided by EarlySense Ltd.:

Primary Outcome Measures:
  • CHF [ Time Frame: 1 month ]

Enrollment: 0
Study Start Date: October 2006
Study Completion Date: March 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00382746

Rambam Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
EarlySense Ltd.
Rambam Health Care Campus
Principal Investigator: Shmuel Rispler, M.D. Rambam Health Care Campus
  More Information Identifier: NCT00382746     History of Changes
Other Study ID Numbers: ES- CI 02
Study First Received: September 28, 2006
Last Updated: July 17, 2016

Keywords provided by EarlySense Ltd.:

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on August 22, 2017