Cardiac Rhythm and Heart Failure PRODUCT SURVEILLANCE REGISTRY {PSR) PLATFORM BASE, Product Surveillance Registry {PSR) Miera All-Comers Regional Evidence Appendix {AREA) {PSR Miera AREA) Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- 1 To estimate the acute major complication rate related to the Micra System and/or the Micra system implant procedure.
研究概览
简要总结
The purpose of the PSR is to provide continuing evaluation and periodic reporting of safety and effectiveness of market-released products for their intended use. PSR data will support post-market surveillance activities and post-approval studies that are initiated by Medtronic, regulated by local governments, or are conducted to fulfill government and/or regulatory authority requests. The PSR will also obtain clinical evidence to guide the development and improvement of medical devices, therapies, device guidelines, patient services/solutions and provide clinical data to support health economics and clinical outcomes research.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements 2.Patient has or is intended to receive or be treated with an eligible Medtronic product 3.Patient is consented prior to the implant procedure.
排除标准
- •Patient who is, or is expected to be, inaccessible for follow-up
- •Participation is excluded by local law
- •Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results.
结局指标
主要结局
1 To estimate the acute major complication rate related to the Micra System and/or the Micra system implant procedure.
时间窗: Baseline Follow up, Implant/ Procedure Follow up, 30 Days and 12 month follow up
2 To estimate the 12 months chronic major complication rate related to the Micra System and/or implant procedure.
时间窗: Baseline Follow up, Implant/ Procedure Follow up, 30 Days and 12 month follow up
次要结局
- 1 Implant/12-month electrical summary(2 Characterization of the implant procedure, anticoagulation strategy (Prior, during & after) procedure.)