Corox OTW Steroid LV Lead Monitoring
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 2
- 主要终点
- Long-term Effectiveness of the COROX Over-the-wire (OTW) Steroid in Providing Biventricular Pacing
研究概览
简要总结
The objective of this post approval registry is to confirm the long-term safety and effectiveness of the Corox Over-the-wire (OTW) Steroid Left Ventricular (LV) lead as used in conjunction with a BIOTRONK cardiac resynchronization therapy defibrillator (CRT-D). The Corox OTW Steroid LV Lead is capable of providing permanent pacing therapy to the left ventricle in a CRT-D system. The following are the specific objectives to be evaluated during this post-approval registry:
- Long-term effectiveness of the COROX OTW Steroid in providing biventricular pacing
- Safety of the COROX OTW Steroid LV pacing lead
详细描述
This post approval registry enrolled 221 patients from 34 centers. The collection of registry data continued for three years for each enrolled subject. Potential patients were screened by the enrolling physician according to the detailed inclusion and exclusion criteria below.
The specific required visits for this registry are: Enrollment, Three-month, Six month, One-year, Routine Follow-Ups (every subsequent 6 months), Interim follow-ups for Corox OTW Steroid LV lead related visits, and Out of Service visit. Data will be collected at each patient follow-up. The programmed pacing parameters, LV pacing impedance, and LV pacing threshold measurement at 0.5ms pulse width will be obtained. The programming parameters will be set to best suit each patient. If adequate system function, including effective CRT, cannot be obtained, the patient should not be selected for the registry.
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
- •Successfully implanted BIOTRONIK CRT-D system, including the Corox OTW Steroid LV Lead, from 1-30 days prior to enrollment
- •Able to understand the nature of the registry and give informed consent
- •Available for follow-up visits on a regular basis at the investigational site
- •Age greater than or equal to 18 years
排除标准
- •Enrolled in another cardiovascular or pharmacological clinical investigation
- •Planned cardiac surgical procedures or interventional measures within the next 6 months
- •Expected to receive a heart transplant within 6 months
- •Life expectancy less than 6 months
- •Presence of another life-threatening, underlying illness separate from their cardiac disorder
- •Pregnancy
结局指标
主要结局
Long-term Effectiveness of the COROX Over-the-wire (OTW) Steroid in Providing Biventricular Pacing
时间窗: All follow-ups for 3 years post implant
Evaluate threshold voltage of the COROX OTW Unipolar Lead.
Safety of the COROX OTW Steroid LV Pacing Lead
时间窗: 3 years post implant
Number of participants with LV lead related adverse events requiring additional invasive intervention to resolve.
次要结局
未报告次要终点