Rheos System for the Treatment of HFpEF Heart Failure
- Conditions
- Heart Failure
- Interventions
- Device: Rheos® system
- Registration Number
- NCT00957073
- Lead Sponsor
- CVRx, Inc.
- 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 NEOâ„¢ LEGACY device for Implantable Pulse Generator (IPG) replacements.
- 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, 2011, the study closed to enrollment before adequate endpoint data was collected and before enrollment was completed; 19 subjects had been randomized, 10 device and 9 medical management. Medical management subjects were withdrawn from the study and subjects who had been implanted with the device were given the opportunity to continue in the study under long-term follow-up; 8 of the 10 device subjects continued in the study. Long-term follow-up visits occurred at 15 and 18 months post-randomization; visits occur semi-annually until study closure.
The study was not stopped for safety or futility, but for business/strategic reasons due to production of a new generation of the device.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- 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.
- Treating physician decision that the subject should not continue with therapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Device Rheos® system Rheos® system
- Primary Outcome Measures
Name Time Method To ascertain long-term adverse events for subjects implanted with the device. Trial duration To systematically and actively ascertain the type, frequency, severity and timing of long-term adverse events in subjects implanted with the device.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
Cardiology Associates of Mobile, Inc.
🇺🇸Mobile, Alabama, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
The Care Group
🇺🇸Indianapolis, Indiana, United States
Drexel University
🇺🇸Philadelphia, Pennsylvania, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Apex Cardiology Consultants
🇺🇸Inglewood, California, United States
Florida Hospital Cardiovascular Institute/Florida Heart Group
🇺🇸Orlando, Florida, United States
Forsyth Cardiovascular Research
🇺🇸Winston-Salem, North Carolina, United States
Lindner Research Center
🇺🇸Cincinnati, Ohio, United States
St. Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
Florida Cardiovascular Institute
🇺🇸Tampa, Florida, United States
Orlando Regional Medical Center
🇺🇸Orlando, Florida, United States
Heart and Vascular Institute of Florida
🇺🇸Saint Petersburg, Florida, United States
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
Liberty Cardiovascular Specialists
🇺🇸Liberty, Missouri, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Cardiovascular Institute of the South
🇺🇸Houma, Louisiana, United States
Northwest Ohio Cardiology Consultants
🇺🇸Toledo, Ohio, United States
Oklahoma Cardiovascular Research Group
🇺🇸Oklahoma City, Oklahoma, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States