试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
This registry will observe patients with symptomatic heart failure with implantable vagus nerve stimulation to provide insights into safety and efficacy during clinical routine.
详细描述
Observational prospective clinical registry in patients with symptomatic heart failure and implanted with the VITARIA System. Assessments will be made during 12 months of post-titration chronic stimulation. The registry will collect patient- and device follow-up data in clinical routine practice at baseline, 3, 6 and 12 months. Clinical routine safety of the therapy will be assessed by the incidence of procedure and device-related events. Clinical routine efficacy will be assessed by changes in cardiac function and heart failure symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and capable of providing informed consent according to national data privacy regulations
- •Patients with NYHA class II/III
- •LVEF≤40% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging, documented less than 12 weeks before implantation of VITARIA system
- •Receiving optimal pharmacological heart failure therapy for at least 3 months
- •Recent implantation of the VITARIA system, prior to device activation
排除标准
- •Hospitalization for heart failure and/or required the use of Heart Failure intravenous therapy in the past 30 days
- •Severe mitral and/or any aortic valve dysfunction
- •History of acute coronary syndrome (ACS) in the past 90 days
- •Stroke or transient ischemic attack (TIA) in the past 90 days
- •Coronary Artery Bypass Surgery (CABG) in the past 90 days
- •PCI in the past 90 days
- •Surgery for Valve replacement (Aortic or mitral valve) in the past 90 days
- •Left ventricular end diastolic diameter (LVEDD) > 80 mm
- •Patients who have had a cardiac resynchronization therapy (CRT) device implanted and have been actively treated with CRT for < 12 months
- •Patients that are scheduled for CRT
- •Patients who are listed for heart transplant or expected to be candidates for heart transplant
- •Patients on hemodialysis or peritoneal dialysis
- •Patients with diabetes (type I or type II) that is being medically treated for autonomic or sensory neuropathy, or measured hemoglobin A1c (HbA1c) above 8.0% in the past 3 months
结局指标
主要结局
Adverse Events
时间窗: 12 months
Serious and non-serious adverse events, according to ISO 14155
LVEF
时间窗: 12 months
Left ventricular ejection fraction
次要结局
- Heart Rate(12 months)
- LVESV(12 months)
- LVESV Index(12 months)
- NYHA Class(12 months)
- Quality of Life(12 months)
- Heart Rate Variability(12 months)