Real-World Experience -- Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry) A Post-Market Registry With the Barostim™ System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- CVRx, Inc.
- 入组人数
- 435
- 试验地点
- 90
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
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.
时间窗: 36 months post-implant
次要结局
未报告次要终点