Status:
ACTIVE_NOT_RECRUITING
Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry)
Lead Sponsor:
CVRx, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
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 fracti...
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...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
June 26 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT04502316
Start Date
June 26 2020
End Date
June 1 2028
Last Update
December 12 2025
Active Locations (45)
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1
Grandview Medical Center
Birmingham, Alabama, United States, 35243
2
Chan Heart Rhythm Institute
Mesa, Arizona, United States, 85206
3
Akil Loli Consulting LLC
Phoenix, Arizona, United States, 85016
4
Cabrillo Cardiology Research Group
Oxnard, California, United States, 93030