Real-World Experience -- Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry) A Post-Market Registry With the Barostim™ System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- CVRx, Inc.
- Enrollment
- 435
- Locations
- 90
- Primary Endpoint
- The primary objective of this post-market registry is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients that were recently implanted with the Barostim System.
Study Overview
Brief Summary
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.
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.
Enrollment data are collected retrospectively after consent and Barostim implant; post-enrollment data are collected prospectively from standard of care follow-up.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Outcomes
Primary Outcomes
The primary objective of this post-market registry is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients that were recently implanted with the Barostim System.
Time Frame: 36 months post-implant
Secondary Outcomes
No secondary outcomes reported