Cardiac Pulmonary Nerve STIMulation in Acute Decompensated Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 7
- 主要终点
- Occurrence of related adverse events
研究概览
简要总结
The STIM-ADHF Study is a multi-center, observational study to assess the performance and safety of the CPNS System in patients with ADHF.
详细描述
The CPNS System is a neuromodulation system used to treat ADHF, a sudden or slow deterioration of chronic heart failure. The CPNS system is intended to provide acute (≤ 5 days) endovascular stimulation of the cardiac autonomic nerves in the right pulmonary artery (PA) in hospitalized ADHF patients. The system consists of an acute temporary neuromodulation stimulation catheter placed in the right pulmonary artery via venous access and a custom stimulator, denoiser, and associated cables. The CN2 Catheter is delivered to the right PA and provides an inotropic and/or lusitropic therapeutic effect by electrical stimulation to the terminal sympathetic nerve branches within the cardio-pulmonary plexus. The study will be conducted at up to 20 study sites worldwide. Up to 50 subjects who meet the eligibility criteria, will be enrolled, treated in-hospital with the Cardionomic CPNS System, monitored closely throughout the hospitalization and followed through 30 days post hospital discharge to evaluate the effect of the CPNS treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Admitted to the hospital or planned to be admitted with a principal diagnosis of acute decompensated heart failure
- •BMI adjusted BNP ≥ 500 pg/mL or NT-proBNP ≥ 2000 pg/mL
- •LVEF ≤ 50%
- •At least one sign/symptom of fluid overload
- •At least one of the following:
- •Inadequate diuretic response
- •At least one sign or symptom of low perfusion
排除标准
- •Received an inotrope during current hospitalization
- •Requires mechanical support
- •Cardiogenic shock or impending cardiogenic shock
- •Multi-organ failure
- •Systolic blood pressure < 80mmHg or > 140mmHg
- •Symptomatic hypotension
- •eGFR < 25 mL/min/1.732
- •Severe hepatic disease
结局指标
主要结局
Occurrence of related adverse events
时间窗: Enrolment to 30 Days post hospital discharge
The following measures will be characterized in all enrolled subjects: occurrence of all procedure, device and therapy related adverse events, serious adverse events and deaths
次要结局
未报告次要终点