BAROSTIM® Hope for Heart Failure Study
- Conditions
- Heart Failure
- Registration Number
- NCT01720160
- Lead Sponsor
- CVRx, Inc.
- Brief Summary
The purpose of this clinical investigation is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM® HOPE4HF Trial (NCT01720160).
- Detailed Description
A prospective, randomized study describing the safety and efficacy of the BAROSTIM NEO System in heart failure subjects with left ventricular ejection fraction equal to or less than 35 percent. Seventy two subjects were randomized; 32 to the medical management arm and 40 to the device arm (38 implanted, 2 withdrawn). The study closed to new enrollments on January 31, 2014. Subjects are in long-term follow-up and are required to have at least one annual visit. During the visit, there will be a physical assessment, a review of medications and serious adverse events.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 98
- Actively participating in the BAROSTIM HOPE4HF Study and currently implanted with the BAROSTIM NEO device with the device turned ON.
- Have signed a revised approved informed consent form for continued participation in this study.
• Treating physician decision that the subject should not continue with therapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Heart failure metric improvements from baseline 12 months To describe changes in measures compared to baseline.
System and procedure related adverse events 6 months To demonstrate the safety of the Neo system in a heart failure population.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Southwest Cardiovascular Associates
🇺🇸Mesa, Arizona, United States
Arizona Heart Rhythm Research Center
🇺🇸Phoenix, Arizona, United States
University of Southern California
🇺🇸Los Angeles, California, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
ACRC - Cardiology
🇺🇸Atlantis, Florida, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Advocate Medical Group
🇺🇸Naperville, Illinois, United States
Cardiovascular Institute of the South
🇺🇸Houma, Louisiana, United States
Scroll for more (13 remaining)Southwest Cardiovascular Associates🇺🇸Mesa, Arizona, United States