Real-World Experience – Barostimâ„¢ 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