Comparison Between Internal and External Chest Impedance Measurement

This study is not yet open for participant recruitment. (see Contacts and Locations)
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:


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
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: 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 September 16, 2014