Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry)
Sponsored by CVRx, Inc.
About this trial
Last updated 16 days ago
Study ID
360059-001
Status
Active not recruiting
Type
Observational
Placebo
No
Accepting
All Ages
All Sexes
Trial Timing
Started 6 years ago
What is this trial about?
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.
What are the participation requirements?
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
Exclusion Criteria