Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure
Sponsor: CVRx, Inc. • ClinicalTrials.gov ID: NCT07232030
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The purpose of BENEFIT-HF is to demonstrate the safety and effectiveness of Baroreflex Activation Therapy (BAT) with the Barostim System in participants with heart failure, defined as NYHA Functional Class II or III, LVEF \< 50% and NT-proBNP \< 5,000 pg/mL despite being treated with Guideline-Directed Medical Therapies (medications and devices). It includes demonstration that treatment with the Barostim System, relative to usual care medical management, reduces the rate of all-cause mortality and Heart Failure Morbidity (Cardiac Transplant, Durable LVAD, or Worsening Heart Failure Events).
Interventions
-
Barostim System
(Device)
Baroreflex Activation Therapy (BAT) using the Barostim System
-
Usual care medical management
(Other)
Usual care medical management alone - no device implant
Eligibility criteria
Conditions
Locations
- Cardiology Associates of Mobile — Mobile, Alabama, United States
- PIH Health Good Samaritan Hospital — Los Angeles, California, United States
- BayCare Health System — Clearwater, Florida, United States
- First Coast Cardiovascular Institute — Jacksonville, Florida, United States
- AdventHealth Orlando — Orlando, Florida, United States
- Tallahassee Research Institute — Tallahassee, Florida, United States
- Tampa General Hospital — Tampa, Florida, United States
- BayCare Health Systems — Tampa, Florida, United States
- Cardiovascular Medicine — Moline, Illinois, United States
- Ascension St. Vincent — Indianapolis, Indiana, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- The Christ Hospital — Cincinnati, Ohio, United States
- Saint Francis Hospital — Tulsa, Oklahoma, United States
- North Central Heart — Sioux Falls, South Dakota, United States
- Erlanger Health — Chattanooga, Tennessee, United States
- Stern Cardiovascular Center — Germantown, Tennessee, United States
- CHRISTUS Trinity Mother Frances — Tyler, Texas, United States
- Marshfield Clinic Research Institute — Marshfield, Wisconsin, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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