Attain Model 4196 Left Ventricular (LV) Lead
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 24
- 主要终点
- Safety (Subjects Without a Model 4196 Lead Related Complication)
研究概览
简要总结
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three or four leads (flexible insulated wires) that are inserted through the veins to the heart. The purpose of this study is to evaluate a new lead for delivering energy to the left ventricle (bottom left chamber of the heart).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •QRS greater than or equal to 120 milliseconds (The QRS interval is a measurement of how the electrical signal involved in a heart beat travels, or is conducted, through the ventricles. A wide QRS (more than 120) suggests that there is a conduction problem, or block, in the ventricles.)
- •Left Ventricular Ejection Fraction (EF) less than or equal to 35 percent (Ejection Fraction is a measurement of how well the left ventricle pumps blood out to the rest of the body. The higher the EF the more blood the ventricle is pumping.)
- •Subject has moderate to severe heart failure despite medications
排除标准
- •Subjects with a previous lead in the left ventricle or previous implant attempt within 30 days of implant or ongoing complications from a previous unsuccessful attempt
- •Subjects with chest pain or who have had a heart attack within the past month before enrollment in the study
- •Subjects that have had certain surgeries on their heart within the past three months
- •Subjects with chronic (permanent) fast heart beats in the upper chambers of the heart (atrial arrhythmias)
结局指标
主要结局
Safety (Subjects Without a Model 4196 Lead Related Complication)
时间窗: One Month
A subject who was free of a Model 4196 lead related complication by one month visit.
Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode)
时间窗: One Month
Model 4196 lead distal tip electrode mean pacing voltage threshold (at 0.5 milliseconds \[ms\])
Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode)
时间窗: Three Months
Model 4196 lead proximal ring electrode mean pacing voltage threshold (at 0.5 milliseconds \[ms\])
次要结局
- Subjects Successfully Implanted With Model 4196 Lead(Implant)
- Subjects Successfully Implanted After Cannulation(Implant)
- All Left Ventricular Leads(Implant)
- All Medtronic Left Ventricular Leads (Attain Family)(Implant)
- Cannulation Time(Implant)
- Fluoroscopy Time(Implant)
- Model 4196 Lead Placement Time(Implant)
- Total Implant Time(Implant)
- Assessment of Lead Handling Characteristics(Implant)
- Electrical Performance - Tip Electrode: Sensing(12-month)
- Electrical Performance - Tip Electrode: LV Voltage Threshold(12-month)
- Electrical Performance -Tip Electrode: Pacing Impedance(12-month)
- Electrical Performance -Ring Electrode: Sensing(Implant)
- Electrical Performance - Ring Electrode: LV Voltage Threshold(12-month)
- Electrical Performance -Ring Electrode: Pacing Impedance(12-Month)
- Summarize All Adverse Events(Up to 18 months)