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EarlySense Monitoring Device Evaluation on CHF Patients

This study has been withdrawn prior to enrollment.
(No need)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00382746
First Posted: September 29, 2006
Last Update Posted: July 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Rambam Health Care Campus
Information provided by:
EarlySense Ltd.
  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

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)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00382746     History of Changes
Other Study ID Numbers: ES- CI 02
First Submitted: September 28, 2006
First Posted: September 29, 2006
Last Update Posted: July 19, 2016
Last Verified: April 2008

Keywords provided by EarlySense Ltd.:
Congestive
Heart
Failure
CHF

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases