Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry)
NCT ID: NCT04502316
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
5000 participants
OBSERVATIONAL
2020-06-26
2028-06-30
Brief Summary
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Detailed Description
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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.
Enrollment data are collected retrospectively after consent and Barostim implant; post-enrollment data are collected prospectively from standard of care follow-up.
Conditions
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Study Design
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COHORT
OTHER
Interventions
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Barostim™ System
Implantation of the Barostim™ System
Eligibility Criteria
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Inclusion Criteria
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
ALL
No
Sponsors
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CVRx, Inc.
INDUSTRY
Responsible Party
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Locations
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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 D.C., District of Columbia, United States
The George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
Orlando Cardiac & Vascular Specialists
Altamonte Springs, Florida, United States
Orlando Heart and Vascular Institute
Altamonte Springs, Florida, United States
Lakewood Cardiovascular
Bradenton, Florida, United States
AMA Heart and Vascular
Bradenton, Florida, United States
Cardiovascular Solutions Institute
Bradenton, Florida, United States
Cardiac Care Group
Cape Coral, Florida, United States
Daytona Heart Group
Daytona Beach, Florida, United States
Florida Heart Rhythm Specialists
Fort Lauderdale, Florida, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Premier Cardiology & Vascular Associates
Maitland, Florida, United States
University of Miami
Miami, Florida, United States
Naples Heart Rhythm Specialists, PA
Naples, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Sarasota Memorial Research Institute (Sarasota Memorial Hospital)
Sarasota, Florida, United States
University of South Florida
Tampa, Florida, United States
Howard T. Tee, M.D., F.A.C.C., F.A.C.P.
Vero Beach, Florida, United States
Florida Cardiology (Guardian Research Organization, LLC)
Winter Park, Florida, United States
University of Chicago
Chicago, Illinois, United States
Cardiovascular Medicine
Moline, Illinois, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Capitol Cardiology Associates
Lanham, Maryland, United States
HeartPlus Diagnostic Center
Jackson, Mississippi, United States
DeGregorio Cardiology
Glen Ridge, New Jersey, United States
Valley Hospital
Ridgewood, New Jersey, United States
Cardio Vascular Health Associates
South River, New Jersey, United States
Capital Cardiology
Albany, New York, United States
Marian David, M.D., P.C
Kew Gardens, New York, United States
Adam Budzikowski PC
Maspeth, New York, United States
Advanced Cardiac Care
Ozone Park, New York, United States
Cone Health
Greensboro, North Carolina, United States
Stern Cardiovascular
Germantown, Tennessee, United States
Austin Heart
Austin, Texas, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
Centra Heart & Vascular Institute
Lynchburg, Virginia, United States
Carient Heart & Vascular
Manassas, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, United States
Countries
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Other Identifiers
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360059-001
Identifier Type: -
Identifier Source: org_study_id
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