BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CVRx, Inc.
- 入组人数
- 500
- 试验地点
- 60
- 主要终点
- Change in Biomarkers from Baseline to 6 months Post-Implant (e.g. NT-pro BNP, eGFR, Troponin HsT, Cystatin C)
研究概览
简要总结
The purpose of this registry (NCT02880618) is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM NEO System in the commercial setting in subjects recently implanted under the CE-Marked indication for heart failure with reduced ejection fraction (HFrEF).
详细描述
Summary:
The CVRx BAROSTIM THERAPY in Heart Failure with Reduced Ejection Fraction (HFrEF) Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for heart failure. Subjects must be enrolled within 30 days from implant. Up to 500 subjects will be enrolled at up to 50 sites. Data should be obtained from standard of care measurements taken prior to implant, at enrollment/baseline, and at 3, 6, and 12 months after the device was implanted, at which time each subject will be exited from the registry.
Eligibility:
Subjects can be included in the Heart Failure with Reduced Ejection Fraction Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications, and are not contraindicated, for the BAROSTIM NEO System in the treatment of heart failure. The BAROSTIM NEO System is indicated for subjects with heart failure, defined as New York Heart Association (NYHA) functional Class III and left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate heart failure guideline directed therapy.
The contraindications are:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has heart failure, defined as New York Heart Association (NYHA) functional Class III and left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate heart failure guideline directed therapy
- •Subject has been implanted with the BAROSTIM NEO System in the past 30 days
- •Subject has signed an Ethics Committee approved informed consent form
排除标准
- •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 to be greater than 50%
- •Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation
结局指标
主要结局
Change in Biomarkers from Baseline to 6 months Post-Implant (e.g. NT-pro BNP, eGFR, Troponin HsT, Cystatin C)
时间窗: Baseline, 6 months post-implant
To demonstrate that that treatment with BAROSTIM NEO improves biomarker results.
Change in Six Minute Hall Walk from Baseline to 6 months Post-Implant
时间窗: Baseline, 6 months post-implant
To demonstrate that that treatment with BAROSTIM NEO improves six-minute hall walk performance.
Change in New York Heart Association Functional Classification at 6 months Post-Implant
时间窗: Baseline, 6 months post-implant
To demonstrate that that treatment with BAROSTIM NEO improves New York Heart Association classification.
Left Ventricular Mass Index Change from Baseline to 6 Months Post-Implant
时间窗: Baseline, 6 months post-implant
To demonstrate that that treatment with BAROSTIM NEO reduces left ventricular mass index.
Number of Hospitalizations over Follow-Up
时间窗: 12 months post-implant
To demonstrate that that treatment with BAROSTIM NEO reduces hospitalizations.
次要结局
未报告次要终点