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Comparison Between Internal and External Chest Impedance Measurement

This study is not yet open for participant recruitment.
Verified February 2011 by Hillel Yaffe Medical Center
Sponsor:
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01296282
First received: February 13, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  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:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Mark Kazatsker, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01296282     History of Changes
Other Study ID Numbers: 0094-10-HYMC
Study First Received: February 13, 2011
Last Updated: February 13, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013