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Sponsored by: |
St. Jude Medical |
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Information provided by: | St. Jude Medical |
ClinicalTrials.gov Identifier: | NCT00500838 |
The intent of this feasibility study is to collect and analyze intra-thoracic impedance measurements from a CRT-D device in a heart failure population.
Condition | Intervention | Phase |
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Heart Failure |
Device: Transthoracic Impedance |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | CRT-D Based Impedance Monitoring Feasibility Study |
Estimated Enrollment: | 75 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | October 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Transthoracic impedance device implanted.
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Device: Transthoracic Impedance
Impedance measures will be automatically collected via the device
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This is a multi-center feasibility study intended to collect information on changes in intra-thoracic impedance measurements from CRT-D devices. In order to obtain an intra-thoracic impedance measurement, the device delivers a subthreshold impulse that measures the resistance between two electrodes.
At the programmed interval, measurements will be obtained between six different lead configurations.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Eligible patients will meet all of the following:
Exclusion Criteria:
Patients will be excluded if they meet any of the following:
United States, Arkansas | |
Baptist Health Medical Center | |
Little Rock, Arkansas, United States, 72205 | |
United States, California | |
Glendale Memorial Hospital | |
Glendale, California, United States, 91204 | |
United States, New Jersey | |
Deborah Heart and Lung | |
Browns Mills, New Jersey, United States, 08015 | |
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29401 |
Principal Investigator: | G. Stephen Greer, MD | Baptist Health |
Responsible Party: | St. Jude Medical, CRMD ( Director, Clinical Affairs ) |
Study ID Numbers: | 40004384 |
Study First Received: | July 11, 2007 |
Last Updated: | September 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00500838 |
Health Authority: | United States: Food and Drug Administration |
Cardiac Resynchronization Therapy Transthoracic Impedance |
Heart Failure Heart Diseases |
Cardiovascular Diseases |