RECRUITING
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Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry)
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.
Conditions:
🦠 Heart Failure
🗓️ Study Start (Actual) 26 June 2020
🗓️ Primary Completion (Estimated) June 2028
✅ Study Completion (Estimated) June 2028
👥 Enrollment (Estimated) 5000
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Birmingham, Alabama, United States
📍 Mesa, Arizona, United States
📍 Phoenix, Arizona, United States
📍 La Mesa, California, United States
📍 Los Angeles, California, United States
📍 Norco, California, United States
📍 Oxnard, California, United States
📍 Torrance, California, United States
📍 Aurora, Colorado, United States
📍 Littleton, Colorado, United States
📍 Washington, District of Columbia, United States
📍 Washington, District of Columbia, United States
📍 Altamonte Springs, Florida, United States
📍 Altamonte Springs, Florida, United States
📍 Bradenton, Florida, United States
📍 Bradenton, Florida, United States
📍 Bradenton, Florida, United States
📍 Cape Coral, Florida, United States
📍 Daytona Beach, Florida, United States
📍 Fort Lauderdale, Florida, United States
📍 Jacksonville, Florida, United States
📍 Maitland, Florida, United States
📍 Miami, Florida, United States
📍 Naples, Florida, United States
📍 Orlando, Florida, United States
📍 Orlando, Florida, United States
📍 Sarasota, Florida, United States
📍 Tampa, Florida, United States
📍 Vero Beach, Florida, United States
📍 Winter Park, Florida, United States
📍 Chicago, Illinois, United States
📍 Moline, Illinois, United States
📍 Baltimore, Maryland, United States
📍 Lanham, Maryland, United States
📍 Jackson, Mississippi, United States
📍 Las Vegas, Nevada, United States
📍 Cedar Knolls, New Jersey, United States
📍 Glen Ridge, New Jersey, United States
📍 Ridgewood, New Jersey, United States
📍 S. River, New Jersey, United States
📍 Albany, New York, United States
📍 Kew Gardens, New York, United States
📍 Maspeth, New York, United States
📍 Ozone Park, New York, United States
📍 Greensboro, North Carolina, United States
📍 Germantown, Tennessee, United States
📍 Austin, Texas, United States
📍 Dallas, Texas, United States
📍 Lynchburg, Virginia, United States
📍 Manassas, Virginia, United States
📍 Milwaukee, Wisconsin, United States
📍 Weston, Wisconsin, United States
More locations available...

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 30 July 2020
  • First Submitted that Met QC Criteria 5 August 2020
  • First Posted 6 August 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 June 2024
  • Last Update Posted 1 July 2024
  • Last Verified June 2024
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