NL-OMON48528已完成不适用
Transvenous Lead Removal Using the Cook Evolution® LEAd Extraction SystEm Post-Market Clinical Study - RELEASE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •A patient is suitable for inclusion in this clinical study if the patient is
- •treated per the IFUs of the Cook lead extraction devices used and the patient
- •meets the following criteria:
- •1. Patients must be 18 years of age or older
- •2. Lead indwell time greater than 1 year
排除标准
- •Patients shall be excluded from enrollment into the clinical study if any of
- •the following are true:
- •1. Patient is unable or unwilling to provide informed consent (per the IRB/EC
- •requirements) to participate in the clinical study
- •2. Investigator intends to treat patient with a non-Cook sheath device
- •3. Patient presents with an extracardiac lead
研究者
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