NCT03261063已完成不适用
China Evera MRI® Study
Medtronic Cardiac Rhythm and Heart Failure3 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年10月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- The proportion of successful MRI scans
研究概览
简要总结
The study is a prospective, single arm, non-blinded, multi-site study conducted in mainland China.
详细描述
The purpose of the China Evera MRI® study is to confirm safety of the Evera MRI ICD System in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur anywhere on the body). Long-term device effects, such as long-term lead integrity, will not be assessed in the China Evera MRI® study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects who are indicated for implantation of an ICD at the time of study enrollment.
- •Subjects who are able to undergo a pectoral implant.
- •Subjects who are able and willing to undergo elective MRI scanning without sedation , .
- •Subjects who are geographically stable and available for follow-up at the study site for the length of the study.
- •Subjects who are at least 18 years of age (or older, if required by local law).
排除标准
- •Subjects with a history of significant tricuspid valvular disease that precludes the ability to place the RV lead. .
- •Subjects who may be contraindicated to the dexamethasone sodium phosphate and/or dexamethasone acetate.
- •Subjects who require a legally authorized representative to obtain informed consent.
- •Subjects with abandoned or capped leads.
- •Subjects who require an indicated MRI scan, other than those specifically described in the China Evera MRI® study, before the one-month post-MRI follow-up (approximately 4 months post-implant).
- •Subjects with a non-MRI compatible device (such as neurostimulators) or material implant (e.g., non-MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys).
- •Subjects with medical conditions that preclude the testing required by the CIP or limit study participation.
- •Subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the China Evera MRI® study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
- •Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within seven (7) days prior to device implant
- •Subjects with exclusion criteria required by local law (e.g., age, breastfeeding).
- •Subjects who are diagnosed with terminal disease with life expectancy less than 4 months.
研究组 & 干预措施
Evera Implanted Group
Experimental
干预措施: Evera MRI ICD System (Device)
结局指标
主要结局
The proportion of successful MRI scans
时间窗: 1 Month Follow up visit after MRI Scan Visit
To summarize the MRI-related event rate within 30 days post-MRI in patients implanted with an Evera MRI device.
次要结局
- The effectiveness of the Evera MRI device post-MRI.(Pre-MRI scan, immediately post MRI scan, 1-week and 1-month post MRI scan.)
研究者
研究点 (3)
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