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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00531661 |
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Date of registration:
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18/09/2007 |
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Primary sponsor: |
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Public title:
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CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
CHAMPION |
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Scientific title:
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CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients |
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Date of first enrolment:
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August 2007 |
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Target sample size:
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550 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00531661 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
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Countries of recruitment
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United States
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Contacts
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Name:
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Phillip Adamson, MD, FACC |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oklahoma Heart Hospital |
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Name:
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William T Abraham, MD, FACC |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Ohio State University Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Contact sponsor for details.
Exclusion Criteria:
Contact sponsor for details.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Heart Failure, Congestive
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Intervention(s)
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Device: HF Pressure Measurement System
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Primary Outcome(s)
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The primary hypothesis is that the TREATMENT group will have a significantly lower rate of HF-related hospitalizations than the CONTROL group.
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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