Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry)

Stopped early

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT04502316

Run by

CVRx, Inc.

People needed

435

Starts

2020-06-26

Expected to finish

2026-06-30

Last updated by the study team

2026-07-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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