BAROSTIM THERAPY™ In Resistant Hypertension: 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
- 52
- 主要终点
- Blood Pressure Changes
研究概览
简要总结
The purpose of this registry (NCT02880631) 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 resistant hypertension.
详细描述
Summary:
The CVRx BAROSTIM THERAPY in Resistant Hypertension Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for resistant hypertension. 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. After 12 months, data may be obtained in six month intervals for up to three years after implant, at which time each subject will be exited from the registry.
Eligibility:
Subjects must sign an Ethics Committee (EC) approved informed consent form for the registry to participate.
Subjects can be included in the Hypertension Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications and contraindications for the BAROSTIM NEO System in the treatment of resistant hypertension. These include:
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
- •Has signed an EC approved informed consent form
- •Has been implanted with the BAROSTIM NEO system in the past 30 days
- •Systolic blood pressure greater than or equal to 140 mmHg, and
- •Resistance to maximally tolerated therapy with a diuretic and two other anti-hypertension medications
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
Blood Pressure Changes
时间窗: Pre-implant baseline to 3 years post-implant
The results of an office cuff blood pressure measurement to be obtained from a time point prior to implant and as close to the implant procedure as possible (baseline), at 3- and 6- and 12-months post-implant, and then every 6 months up to 3 years from implant.
Cardiovascular Medication Changes
时间窗: Post-implant enrollment to 3 years post-implant
Information on currently-utilized doses of cardiovascular medications will be collected at pre-implant baseline, 3- and 6- and 12-months post-implant, and then every 6 months up to 3 years from implant.
Number of Health Care Utilizations
时间窗: 3 months post-implant to 3 years post-implant
Health care utilization information (e.g. heart failure hospitalizations) is collected at 3- and 6- and 12-months post-implant, and then every 6 months up to 3 years from implant.
次要结局
未报告次要终点