Observation of Clinical Routine Care for Patients Implanted With BIOTRONIK Devices Used for Conduction System Pacing (CSP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 40
- 主要终点
- SADE-d free rate related to any investigatonal device
研究概览
简要总结
The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Guideline indication for pacemaker or cardiac resynchronization therapy with or without defibrillation function (CRT-P/-D)
- •Patient is intended for a de novo implantation and LBBAP therapy with an investigational generator and an investigational lead OR has just been implanted with an investigational generator and an investigational lead positioned permanently deep within the intraventricular septum and has not yet been discharged from the hospital OR transitions from the BIO|MASTER.CSP study
- •Ability to understand the nature of the study
- •Ability and willingness to perform all follow-up visits
- •Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept
排除标准
- •Planned dation from intended use
- •Planned for cardiac surgical procedures, heart transplantation or interventional measures other than the study procedure within one year after enrollment
- •Life-expectancy less than 12 months
- •Pregnant or breast feeding
- •Age less than 18 years
- •Participation in an interventional clinical investigation, except for submodules within this study.
结局指标
主要结局
SADE-d free rate related to any investigatonal device
时间窗: throughout study duration, average of 4 years; annual evaluations
Rate of serious adverse device effects possible, probable or causal related to any investigational device.
Rate of successful acute implantation in LBBAP using investigational devices in LBBAP
时间窗: Day 1
All implantations, in which the investigator decides to leave the Solia CSP S pacing lead permanently deep within the intraventricular septum are counted as acute success.
Capture type at implantation
时间窗: Day 1
The investigator confirms the type of pacing capture for any implantation in which the pacing lead is permanently positioned deep within the interventricular septum. Success rates for LBBAP and CSP are determined based on ECG parameters.
Long-term maintenance of LBBAP
时间窗: throughout study duration, average of 4 years; annual evaluations
The investigator is asked to assess the effectiveness of LBBAP during follow-up based on the interpretation of a 12-lead ECG recording.
Electrical parameters - pacing threshold
时间窗: throughout study duration, average of 4 years; annual evaluations
The investigators will be asked to record the pacing thresholds (Volts) of the LBBAP leads at a pulse width of 0.4 ms.
Electrical parameters - sensing amplitude
时间窗: throughout study duration, average of 4 years; annual evaluations
The investigators will be asked to record the sensing amplitude (Millivolts) of the LBBAP leads.
Electrical parameters - pacing impedance
时间窗: throughout study duration, average of 4 years; annual evaluations
The investigators will be asked to record the lead pacing impedance (Ohms) of the LBBAP leads.
次要结局
未报告次要终点