Real-World Experience - Barostimâ„¢ Advancing the Level of Clinical Evidence (REBALANCE Registry)
Purpose
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.
Condition
- Heart Failure
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Criteria
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
Washington, District of Columbia 20010
Vero Beach, Florida 32960
John Rhoades
772-299-1901
More Details
- Status
- Recruiting
- Sponsor
- CVRx, Inc.
Detailed Description
Summary: The CVRx REBALANCE Registry includes patients who have been implanted with the Barostim System. Up to 5,000 patients will be enrolled. Data should be obtained from evaluations taken prior to implant, at implant, and every six months after device implant, up to the 36-month visit at which time each patient will be exited from the registry.