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

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