HEmodynamic Assessment of Optimal Left Heart Lead Placement for Heart Failure Enabled by Magnetic Navigation
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Stereotaxis
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Reduction in end systolic volume (ESV)
研究概览
简要总结
The literature shows that approximately 40% of individuals who receive a cardiac resynchronization therapy (CRT) device for symptomatic congestive heart failure (CHF) do not have a clinical benefit from the device. The HEAL-HF protocol will compare the outcomes of conventionally placed CRT devices with magnetically placed CRT devices by assessing hemodynamic parameters during the magnetic placement of the left ventricular (LV) lead.
详细描述
Baseline information will be obtained including QoL, 6-minute walk, and echo measurements. The patient will be randomized to receive a conventionally-placed LV lead or randomized to receive a magnetically-placed LV lead. The magnetic group will have acute hemodynamics assessed during the procedure to evaluate the best response of the left ventricle during pacing. Patients will be followed for 6 months with a re-evaluation of the baseline tests to assess the change in HF symptoms. Adverse events will also be recorded during the follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic cardiomyopathy
- •Ejection Fraction (EF) <= 35%
- •QRS duration >= 120 msec
- •Standard heart failure (HF) oral medications for at least 1 month
- •Evidence of mechanical dyssynchrony
- •NYHA Class III or IV
排除标准
- •Persistent or chronic atrial fibrillation (AF)
- •Hemodynamically unstable or uncontrolled arrhythmias
- •Unstable angina
- •Aortic valve (AV) insufficiency or stenosis
- •Mitral valve (MV) regurgitation > 2+
- •Active infection
- •Contraindications for heparin
- •Dependence on atrial pacing
结局指标
主要结局
Reduction in end systolic volume (ESV)
时间窗: 6 months
次要结局
- New York Heart Association (NYHA) Class(6 months)
- 6 minute walk(6 months)
- Quality of life (QoL)(6 months)
- Cardiac-related mortality(6 months)
- HF-related hospitalizations(6 months)