Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2,226
- 试验地点
- 116
- 主要终点
- Sentus QP Related Complication-free Rate
研究概览
简要总结
The QP ExCELs study is designed to confirm safety and efficacy of the BIOTRONIK Sentus OTW QP left ventricular leads to satisfy FDA requirements for regulatory approval of the leads in the US. The Sentus OTW QP leads received FDA approval on May 4, 2017.
Long-term safety of the BIOTRONIK Sentus OTW QP left ventricular leads will be confirmed during the ongoing post approval phase (US sites only).
A protocol update was implemented on September 6, 2019 to transition the long-term follow up for the ongoing Sentus QP Study to a new EP PASSION real-world data methodology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Standard CRT-D indication according to clinical routine
- •De novo implantation or upgrade from existing ICD or pacemaker implant utilizing a BIOTRONIK CRT-D system with IS4 LV port and Sentus QP LV lead
- •Patient is able to understand the nature of the clinical investigation and provide written informed consent
- •Patient is able and willing to complete all routine study visits at the investigational site through 5 years of follow-up
- •Patient accepts Home Monitoring® concept
- •Age ≥ 18 years
排除标准
- •Chronic atrial fibrillation
- •Contraindication to CRT-D therapy
- •Currently implanted with an endocardial or epicardial left ventricular lead or had prior attempt to place a left ventricular lead
- •Cardiac surgical procedure, such as coronary artery bypass graft or valve surgery that is planned to occur within 6 months after implant or ablation that is planned to occur within 90 days after implant (ablations planned to occur prior to or at implant are not exclusionary)
- •Expected to receive a heart transplant or ventricular assist device within 6 months
- •Life expectancy less than 12 months
- •Participation in any other investigational cardiac clinical investigation during the course of the study
- •Presence of another life-threatening, underlying illness separate from their cardiac disorder
- •Pregnant or breast-feeding at time of enrollment
结局指标
主要结局
Sentus QP Related Complication-free Rate
时间窗: Up to 4 years
The purpose of primary endpoint 3 is to evaluate the Sentus QP related complication-free rate through study termination (post approval phase). This is evaluated as a percentage of participants without a complication.
Percentage of Participants With Acceptable Pacing Threshold of Sentus QP Lead in Permanently Programmed Vector at 3 Months
时间窗: 3 months
The purpose of primary endpoint 2 is to evaluate the LV lead pacing threshold for the permanently programmed pacing vector at 3 months post-implant.This was evaluated by performing an exact, binomial test comparing the percentage of participants with acceptable pacing thresholds to a performance goal of 88%. LV threshold values of less than or equal to 2.5 V at 0.4 ms in the permanently programmed vector are considered acceptable.
Sentus QP Related Complication-free Rate Through 6 Months
时间窗: 6 months
The purpose of primary endpoint 1 is to evaluate the Sentus QP related complication-free rate through 6 months post-implant. This is evaluated as a percentage of participants without a complication.
次要结局
- Sentus QP Acceptable Pacing Threshold in Novel Vectors at 3 Months(3 months)
- Sentus QP Acceptable Pacing Threshold in Permanently Programmed Vector at 3 Months Per Lead Model(3 months)
- Sentus QP Time to Complication(6 months)
- Number of Participants Successfully Reprogrammed to Resolve Phrenic Nerve Stimulation or High Pacing Threshold(12 months)
- Sentus QP Acceptable R-wave Sensed Amplitude at 3 Months Per Lead Model(3 months)
- Sentus QP Acceptable Pacing Impedance at 3 Months Per Lead Model(3 months)
- Sentus QP Related Complication-free Rate Per Lead Model(Up to 4 years)
- Individual Sentus QP Adverse Event Rates(Up to 4 years)