Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry)
- Conditions
- Heart Failure
- Registration Number
- NCT04502316
- Lead Sponsor
- CVRx, Inc.
- Brief Summary
The purpose of this registry is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients with heart failure with reduced ejection fraction (HFrEF) that were recently implanted with the Barostim System.
- Detailed Description
Summary:
The CVRx REBALANCE Registry includes patients who have been implanted with the Barostim System. Up to 5,000 patients will be enrolled. Data should be obtained from evaluations taken prior to implant, at implant, and every six months after device implant, up to the 36-month visit at which time each patient will be exited from the registry.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 5000
- Patients can be included in the registry if they were implanted with a de novo Barostim System. Patients must sign an informed consent form after implantation with the Barostim System in order to participate in the registry.
Indications:
The Barostim System is indicated for the improvement of symptoms of heart failure - quality of life, six-minute hall walk and functional status - for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, a NT-proBNP < 1600 pg/ml and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.
Contraindications:
- Bilateral carotid bifurcations located above the level of the mandible
- Baroreflex failure or autonomic neuropathy
- Uncontrolled, symptomatic cardiac bradyarrhythmias
- Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation greater than 50%
- Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation
- Known allergy to silicone or titanium
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of serious adverse events related to the system or implant procedure 36 months post-implant Serious adverse events related to the system or implant procedure through 36 months post-implant
- Secondary Outcome Measures
Name Time Method Number of heart failure hospitalizations 36 months post-implant Number of heart failure hospitalizations through 36 months post-implant
Change NYHA Classification 36 months post-implant Changes in NYHA Classification through 36 months post-implant
Duration of heart failure hospitalizations 36 months post-implant Duration of heart failure hospitalizations through 36 months post-implant
Change in NT-proBNP 36 months post-implant Changes in NT-proBNP through 36 months post-implant
Change in LVEF 36 months post-implant Changes in LVEF through 36 months post-implant
Change in Six Minute Hall Walk 36 months post-implant Changes in Six Minute Hall Walk distance through 36 months post-implant
Trial Locations
- Locations (46)
Grandview Medical Center
🇺🇸Birmingham, Alabama, United States
Chan Heart Rhythm Institute
🇺🇸Mesa, Arizona, United States
Akil Loli Consulting LLC
🇺🇸Phoenix, Arizona, United States
Cabrillo Cardiology Research Group
🇺🇸Oxnard, California, United States
COR Healthcare Medical Associates
🇺🇸Torrance, California, United States
Aurora Denver Cardiology Associates
🇺🇸Aurora, Colorado, United States
South Denver Cardiology Associates, P.C.
🇺🇸Littleton, Colorado, United States
Medstar Health Research Insitutute
🇺🇸Washington, District of Columbia, United States
The George Washington University Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
Orlando Cardiac & Vascular Specialists
🇺🇸Altamonte Springs, Florida, United States
Scroll for more (36 remaining)Grandview Medical Center🇺🇸Birmingham, Alabama, United States