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Comparison Between Internal and External Chest Impedance Measurement

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01296282
First Posted: February 15, 2011
Last Update Posted: February 15, 2011
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.
Information provided by:
Hillel Yaffe Medical Center
  Purpose
To compare two methods of chest impedance: the Medtronics Optivol Measurement via CRT pacemakers for patients with heart failure and external non-invasive measurement

Condition Intervention
Heart Failure Device: Medronics CRT Optivol Impedance Measurement Device: External Thoracic Impedance Measurement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • External measurement of chest impedance can be effective in monitoring heart failure patients [ Time Frame: Three years ]

Estimated Enrollment: 50
Study Start Date: March 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Heart failure patients Device: Medronics CRT Optivol Impedance Measurement
Pacemaker
Device: External Thoracic Impedance Measurement

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with heart failure with CRT pacemaker
Criteria

Inclusion Criteria:

  • CRT-implanted patients with heart failure

Exclusion Criteria:

  • All others
  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): NCT01296282


Contacts
Contact: Mark Kazatsker, MD 972-4-630-4656 markk@hy.health.gov.il

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Principal Investigator: Mark Kazatsker, MD         
Sponsors and Collaborators
Hillel Yaffe Medical Center
  More Information

Responsible Party: Dr. Mark Kazatsker, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01296282     History of Changes
Other Study ID Numbers: 0094-10-HYMC
First Submitted: February 13, 2011
First Posted: February 15, 2011
Last Update Posted: February 15, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases


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