QuickFlex Micro Model 1258T Left Heart Pacing Lead
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 26
- 主要终点
- Freedom From Left Ventricular Lead-related Complications
研究概览
简要总结
This is a prospective, multi-center non-randomized clinical study to evaluate the safety and efficacy of the QuickFlex Micro Model 1258T left ventricular lead in a heart failure patient population. The study will be conducted at a maximum of 20 investigational centers located in the United States and a total of 68 patients will be enrolled.
详细描述
The investigational left heart lead, QuickFlex Model 1258T, will be implanted with a legally marketed St. Jude Medical cardiac resynchronization therapy implantable cardioverter defibrillator (CRT-D) device.
Patients will be followed at Pre-Discharge, 1-Month, 3-Month,and then every 6 months until the end of the study.
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
- •Approved indication for CRT-D system
排除标准
- •Previous cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment
- •Previous left ventricular (LV) lead implant
- •Have had a heart attack,unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty (PTCA),coronary artery bypass grafting (CABG), Stent) within 40 days prior to enrollment
研究组 & 干预措施
QuickFlex micro 1258T left heart lead
干预措施: QuickFlex Micro Model 1258T Left Heart Lead (Device)
结局指标
主要结局
Freedom From Left Ventricular Lead-related Complications
时间窗: 3 months
A Kaplan-Meier survival analysis was carried out for left ventricular lead related complications through 3 months. Percentage of patients who remained free from complications at 3 months was reported.
Percentage of Successful Left Ventricular Lead Implants
时间窗: 3 months
Left ventricular lead implant success rate was calculated as the total number of patients who had a successful implant of the left ventricular QuickFlex Micro Model 1258T lead divided by the total number of patients who had an attempted implant. A successful implant was defined as the placement of the left ventricular lead in the coronary sinus for the purposes of pacing of the left ventricle with connection to the pulse generator.
Left Ventricular Bipolar Pacing Capture Threshold (Volts)
时间窗: 3 months
The mean left ventricular capture threshold (amount of energy needed to pace the heart) is reported. An overall mean capture threshold of \< 3 volts is required to meet this endpoint.
次要结局
未报告次要终点