The STOP-ADHF Study: Stimulation of the Cardiopulmonary Nervous System in Acute Decompensated Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 25
- 主要终点
- Safety Measures
研究概览
简要总结
STOP-ADHF Study: An evaluation of the safety and performance of the Cardionomic Cardiac Pulmonary Nerve Stimulation (CPNS) system in patients with acute decompensated heart failure.
详细描述
The STOP-ADHF is a prospective, two-arm, multi-center study to evaluate the safety and performance of the CPNS System in patients with acute decompensated heart failure (ADHF).
The CPNS System is a neuromodulation system, intended to provide acute (≤5 days) endovascular stimulation of the cardiac autonomic nerves in the right pulmonary artery. The system consists of a temporary neuromodulation stimulator catheter and a stimulator.
Approximately 90 patients will be enrolled in the study and will be followed up through 6-months post-discharge from the hospital. Patients enrolled in the treatment group will receive CPNS therapy and followed closely in an intensive care unit setting. Patients enrolled in the control arm in will receive standard treatment for their heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 hospital with a principal diagnosis of ADHF
- •BMI adjusted BNP ≥ 500 pg/mL or NT-proBNP ≥ 2000 pg/mL
- •LVEF ≤ 50%
- •At least one sign or symptom of fluid overload despite the administration of IV furosemide (or equivalent) (at least 40 mg or equivalent)
排除标准
- •Received a high dose inotrope or Levosimendan during current hospitalization or treatment with a low dose inotriope within 24 hours before enrollment
- •Requires mechanical support
- •Cardiogenic shock or impending cardiogenic shock
- •Systolic blood pressure < 80mmHg or > 140mmHg
- •Symptomatic hypotension
- •eGFR < 25 mL/min/1.732
研究组 & 干预措施
CPNS Therapy
Treatment with CPNS system: Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care
干预措施: Standard of care (Other)
CPNS Therapy
Treatment with CPNS system: Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care
干预措施: CPNS Therapy (Device)
Standard of Care
Available standard treatment
干预措施: Standard of care (Other)
结局指标
主要结局
Safety Measures
时间窗: 6 months
The occurrence of all system and/or procedure related adverse events and serious adverse events and deaths
次要结局
未报告次要终点