Status:
COMPLETED
Rheos System for the Treatment of HFpEF Heart Failure
Lead Sponsor:
CVRx, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The purpose of this clinical investigation (NCT00957073) is to continue long-term follow-up of device arm subjects enrolled in the HOPE4HF Trial, utilizing the BAROSTIM NEO™ LEGACY device for Implanta...
Detailed Description
The initial trial design randomized subjects in a 2:1 ratio to receive a Rheos system plus medical management (Device Arm) or to receive medical management alone (Medical Management Arm). On March 24,...
Eligibility Criteria
Inclusion
- Currently implanted with the Rheos device and actively participating in the HOPE4HF Trial (G090001).
- Have signed a CVRx, FDA and Institutional Review Board (IRB) approved informed consent form for participation in this study.
Exclusion
- 1\. Treating physician decision that the subject should not continue with therapy.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00957073
Start Date
August 1 2009
End Date
April 1 2021
Last Update
April 8 2021
Active Locations (22)
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1
Cardiology Associates of Mobile, Inc.
Mobile, Alabama, United States, 36608
2
Apex Cardiology Consultants
Inglewood, California, United States, 90301
3
University of Southern California
Los Angeles, California, United States, 90033
4
St. Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105