Evera MRIâ„¢ Study
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 275
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
Medtronic, Inc. is sponsoring the Evera MRIâ„¢ study. This study is a prospective, randomized
controlled, non-blinded, multi-site worldwide study. The purpose of the Evera MRIâ„¢ study is to
confirm safety and efficacy of the Evera MRIâ„¢ 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). The data collected in the Evera MRIâ„¢ study may be used to support regulatory
submissions for the U.S. and other geographies that require human clinical trial data in order to
obtain market approval for devices or labeling changes for the system or its successors. Longterm
device effects, such as long-term lead integrity, will not be assessed in the Evera MRIâ„¢
study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who are indicated for implantation of an ICD at the time of study enrollment.
- •o Subjects who are able to undergo a pectoral implant.
- •o Subjects who are receiving an ICD for the first time.
- •o Subjects who are able and willing to undergo elective MRI scanning without sedation.7,8 o 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
- •o Subjects for whom a single dose of 1.0mg dexamethasone sodium phosphate and/or dexamethasone acetate may be contraindicated.
- •o Subjects who require a legally authorized representative to obtain informed consent.
- •o Subjects undergoing device upgrades, change-outs, lead extractions, and/or lead or device revisions.
- •o Subjects with abandoned or capped leads.
- •o Subjects who require an indicated MRI scan, other than those specifically described in the Evera MRIâ„¢ study, before the one-month post-MRI/waiting period follow-up (approximately 4 months post-implant).
- •o 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).
- •o Subjects with medical conditions that preclude the testing required by the CIP or limit study participation.
- •o 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 Evera MRIâ„¢ study.
- •Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
- •o 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.10 o Subjects with exclusion criteria required by local law (e.g., age, breastfeeding).
结局指标
主要结局
Safety
时间窗: After 30 days
o To demonstrate an acceptable MRI-related event-free rate.
时间窗: After 30 days
Efficacy
时间窗: After 30 days
o To demonstrate that the proportion of patients whose ventricular pacing capture
时间窗: After 30 days
threshold increases significantly one month post-MRI/waiting period is similar
时间窗: After 30 days
between the MRI group and the control group.
时间窗: After 30 days
次要结局
- To demonstrate an acceptable system-related complication rate.(o To demonstrate the system integrity of the high-voltage ICD component after MRI)