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:
Hillel Yaffe Medical Center
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
| Tracking Information | |||||
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| First Received Date ICMJE | February 13, 2011 | ||||
| Last Updated Date | February 13, 2011 | ||||
| Start Date ICMJE | March 2011 | ||||
| Estimated Primary Completion Date | April 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
External measurement of chest impedance can be effective in monitoring heart failure patients [ Time Frame: Three years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison Between Internal and External Chest Impedance Measurement | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | To compare two methods of chest impedance: the Medtronics Optivol Measurement via CRT pacemakers for patients with heart failure and external non-invasive measurement |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients with heart failure with CRT pacemaker |
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| Condition ICMJE | Heart Failure | ||||
| Intervention ICMJE |
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| Study Group/Cohort (s) | Heart failure patients
Interventions:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | April 2015 | ||||
| Estimated Primary Completion Date | April 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01296282 | ||||
| Other Study ID Numbers ICMJE | 0094-10-HYMC | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr. Mark Kazatsker, Hillel Yaffe Medical Center | ||||
| Study Sponsor ICMJE | Hillel Yaffe Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Hillel Yaffe Medical Center | ||||
| Verification Date | February 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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