BIO|MASTER.Selectra 3D Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Selectra 3D-related SADE-free rate
研究概览
简要总结
Study investigating the guiding catheter Selectra 3D
详细描述
The guiding catheter 'Selectra 3D' is a catheter that is intended to support the implantation of a pacemaker lead in untypical positions in the heart like in the His- bundle area.
This study is designed as post market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the guiding catheter Selectra 3D that remained unrevealed even after risk analysis, risk mitigation and successful conformity assessment. Moreover, the study aims at providing additional PMCF data, as required by regulatory authorities. Furthermore, the performance and efficacy of the Selectra 3D shall be assessed. The results will be used for updating the clinical evaluation.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Standard indication for de novo pacemaker or cardiac resynchronization implantation
- •The patient is intended for guiding catheter based implantation of a pacemaker system
- •Patient is able to understand the nature of the study and has provided written informed consent
- •Patient is willing and able to perform all follow up visits at the study site
- •Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring® concept
排除标准
- •AV block with no escape rhythm or broad QRS escape rhythm
- •Standard contraindications for use of the investigational devices:
- •Existing or possible occlusion of the coronary vessels or unsuitable anatomy of the coronary veins
- •Active systemic infection
- •Mechanical tricuspid valve prosthesis or severe tricuspid valve diseases
- •Intolerance against dexamethasone acetate
- •Planned cardiac surgical procedures or interventional measures in addition to the study procedure within the next 6 months
- •Expected to receive heart transplantation or ventricular assist device within 1 year
- •Patient is pregnant or breast feeding
- •Less than 18 years old
- •Participating in another interventional clinical investigation
- •Life-expectancy is less than 1 year
结局指标
主要结局
Selectra 3D-related SADE-free rate
时间窗: 7 days after implantation
Selectra 3D-related Serious adverse device effect rate
次要结局
- Successful implantation rate(At the day of implantation)
- Appropriateness of sensing and pacing of Solia S(12 months)
- SADE-free rate of Solia S(12 months)