NL-OMON50027已完成不适用
Clinical Investigation of the ENO/TEO/OTO Pacing System under MRI environment - CAPRI
Microport CRM B.V.0 个研究点目标入组 15 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Implanted with an ENO/TEO/OTO single or dual chamber pacemaker system with Vega
- •Agree to undergo a non-clinically indicated MRI scan, without intravenous
- •injection or sedation.
- •Informed consent.
- •Available for follow-up.
排除标准
- •Included in another study, that may confound results in this study.
- •Presence of other cardiac implants.
- •Presence of other - non-MRI compatible - implants.
- •History of brain aneurysm with ferromagnetic clipping.
- •Presence of cochlear implants.
- •Tattoos in area where MRI coil is placed.
- •Planned cardiac surgery within 3 months of inclusion.
- •Planned MRI scan within 3 months of inclusion.
- •Aged under 18, in detention, or under guardianship.
- •Known pregnancy, breast-feeding or of child-bearing age without adequate
- •contraceptive method.
- •Unavailable for follow-up.
- •Conflict of interest with sponsor, investigator or institution.
研究者
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