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Main
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Note: This record shows only 22 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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19 April 2021 |
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Main ID: |
NCT00957073 |
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Date of registration:
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10/08/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Rheos System for the Treatment of HFpEF Heart Failure
HOPE4HF |
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Scientific title:
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Health Outcomes Prospective Evaluation for Heart Failure With Ejection Fraction (EF) = 40% |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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19 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00957073 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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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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Faiez Zannad, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Inserm Centre d'Investigation, CHU de Nancy |
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Name:
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JoAnn Lindenfield, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vanderbilt Heart and Vascular Institute |
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Name:
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William Abraham, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ohio State University |
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Name:
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Michael Zile, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical University of South Carolina |
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Name:
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Fred Weaver, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Southern California |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Currently implanted with the Rheos device and actively participating in the HOPE4HF
Trial (G090001).
2. Have signed a CVRx, FDA and Institutional Review Board (IRB) approved informed consent
form for participation in this study.
Exclusion Criteria:
1. Treating physician decision that the subject should not continue with therapy.
Age minimum:
21 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Heart Failure
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Intervention(s)
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Device: Rheos® system
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Primary Outcome(s)
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To ascertain long-term adverse events for subjects implanted with the device.
[Time Frame: Trial duration]
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Secondary ID(s)
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360017-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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