China CIED 3.0T MRI Performance Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 5
- 主要终点
- The Occurrence of an MRI-related Event for CIED
研究概览
简要总结
The purpose of the China CIED 3.0T MRI Performance Study is to confirm safety of SureScan CIED in the clinical 3.0T MRI environment when subjects receive MRI scans. All subjects will have required follow-up visits at baseline, MRI visit, 1-month post-MRI. The MRI scans will occur at the MRI visit. The MRI scan region will be determined by investigator according to the subject's clinical condition.
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 were implanted an SureScan system CIED over 6 weeks at the time of signing ICF.
- •Subjects who are able and willing to undergo elective MRI scanning without sedation.
- •Subjects who were implanted an SureScan system CIED in the pectoral region.
- •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 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 CIED 3.0T MRI performance study, before the 1-month post-MRI follow-up.
- •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 SureScan 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.
研究组 & 干预措施
Subjects with market released 3.0T conditional CIED systems undergoing 3.0T MRI scan attempt
This was a single-arm study to confirm safety and effectiveness of the SureScan CIED System in the clinical MRI environment when subjects receive 3.0T MRI scans without positioning restrictions (MRI scans may occur anywhere on the body). Study devices refer to China market released 3.0T Magnetic resonance (MR) conditional CIED systems. Subjects implanted with a SureScan study device who underwent a 3.0T MRI scan attempt were considered in endpoint analyses.
干预措施: China market released 3.0T Magnetic resonance (MR) conditional CIED systems (Device)
结局指标
主要结局
The Occurrence of an MRI-related Event for CIED
时间窗: The event will be collected within 30 days after MRI visit.
The primary objective was to demonstrate the safety of SureScan system CIED in clinical 3.0T MRI environment within 1-month post-MRI scan. Specifically, it was hypothesized that the MRI-related event-free rate within 1-month post-MRI to be greater than 90%. The proportion of subjects free from MRI-related events was calculated by dividing the number of subjects without an MRI-related event by the number of subjects at risk for an event. The occurrence of any of the following within 30 days after a 3.0T MRI scan would be considered an MRI-related event: (1) Medical advisor-assessed MRI-related complication within 30 days post-MRI (for iPG, ICD or CRT-D); (2) Medical advisor-assessed right ventricular MRI-related loss of capture within 30 days post-MRI (for iPG, ICD or CRT-D); (3) Sustained tachyarrhythmia originating during SureScan programming, requiring immediate treatment (defined as ATP, device shock, or external shock), as assessed by a medical advisor (for ICD or CRT-D).
次要结局
- The Changes in Atrial and Ventricular Pacing Capture Thresholds From Pre-MRI to 1-month Post-MRI Scan.(The evaluation will be compared from pre-MRI to 1-month post-MRI scan)