CELESTIAL Post Approval Registry: Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar Post Approval Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,499
- 主要终点
- Percentage of Subjects Who Are Free of Complications Related to the Corox LV Lead
研究概览
简要总结
The objective of this study is to confirm the long-term safety and reliability of the Corox OTW BP left ventricular (LV) pacing lead. As a condition of approval, the FDA required that a registry documenting the post approval clinical experience of these leads be designed and implemented.
详细描述
This study is an FDA-required, multi-center, prospective, non-randomized, data collection registry. Eligible patients must have been successfully implanted with a Corox OTW BP, Corox OTW-S BP, or Corox OTW-L BP LV lead with a BIOTRONIK CRT device and consented and enrolled between 7-180 days following implant. At least 2500 patients will be enrolled in this post-approval registry, and each patient will be followed for five years post-implant.
Safety will be evaluated based on the analysis of the overall incidence of lead-related adverse events that require additional invasive intervention. In addition, each individual adverse event will be separately investigated. Lead parameters for sensing, pacing thresholds, and impedance will also be evaluated. Reporting of all adverse events will be performed twice a year in order to identify and characterize any trends in adverse events, failure modes, or failure rates.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 system, including a Corox BP LV lead, from 7-180 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 any IDE clinical study
- •Planned cardiac surgical procedures or interventional measures within the next 6 months
- •Expected to receive a heart transplant within 1 year
- •Life expectancy less than 1 year
- •Presence of another life-threatening, underlying illness separate from their cardiac disorder
- •Pregnancy
- •Inability to provide date of implant, devices implanted, age, gender, and whether the patient experienced any protocol-defined adverse events since implant
结局指标
主要结局
Percentage of Subjects Who Are Free of Complications Related to the Corox LV Lead
时间窗: 5 years
The overall incidence of serious adverse events that require additional invasive intervention to resolve, related to the Corox BP LV leads implanted with either BIOTRONIK CRT-P or CRT-D devices.This was evaluated as a serious adverse event free-rate (SAEFR).
Percentage of Subjects Experiencing Individual Complications
时间窗: 5 years
Evaluation of the individual types of serious adverse events contributing to primary outcome 1.
次要结局
- Overall Incidence of Primary Endpoint 1 Serious Adverse Events for Each Corox BP Lead Model(5 years)
- Mean Successful Biventricular Pacing in Subjects at the 5 Year In-office Visit.(5 years)
- Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint(5 years)
- Corox BP LV Lead Pacing Threshold Measurements(5 years)
- Corox BP LV Lead Sensing Measurements(5 years)
- Corox BP LV Lead Impedance Measurements(5 years)
- Pacing Threshold Measurements Per Corox BP LV Lead Model(5 years)
- Sensing Measurements Per Corox BP LV Lead Model(5 years)
- Impedance Measurements Per Corox BP LV Lead Model(5 years)
- Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model(5 years)