ProMRI 3T ENHANCED Master Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 12
- 主要终点
- Decrease in sensing amplitude ratios between 1-month post-MRI and pre-MRI
研究概览
简要总结
The investigation is designed to provide supporting evidence for the clinical safety of the Biotronik's new Implantable Cardioverter Defibrillator systems when used under specific 3 Tesla MR conditions .
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Implanted with Implantable Cardioverter Defibrillator (ICD) system according to Clinical Investigational Plan (CIP)
- •ICD system was implanted in the pectoral region
- •Implantation at least 5 weeks prior to enrollment date
- •Patient body height ≥ 140 cm
- •Age ≥ 18 years
- •Right Ventricular pacing threshold (at 0.4 ms) measurable and ≤ 2.0 V
- •Written informed consent
- •Able and willing to complete MRI testing
- •Able and willing to complete all testing required by the clinical protocol
- •Available for all follow-up visits at the investigational site
排除标准
- •Standard contraindication for MRI scans
- •Patient shows signs of a twiddler's syndrome, i.e. fiddles with implant
- •Explantation, exchange or reposition of ICD or lead within 5 weeks prior to enrollment date
- •Charging status of the battery is Elective Replacement Indicator (ERI) or End of Service (EOS)
- •MRI scan within 5 weeks prior to enrollment date
- •R-wave sensing amplitude < 6.5 millivolt
- •Lead impedance less than 200 or greater than 1500 Ohm
- •Life expectancy of less than six months
- •Cardiac surgery in the next six months
- •Pregnant or breastfeeding
- •Participation in another interventional clinical investigation
结局指标
主要结局
Decrease in sensing amplitude ratios between 1-month post-MRI and pre-MRI
时间窗: 1 Month
Evaluate the percentage of ICD leads with a decrease in the sensing amplitude ratio measured between the Pre-MRI and 1-month post-MRI
Increase in pacing thresholds ratios measured between 1-month post-MRI and pre-MRI
时间窗: 1 Month
Evaluate the percentage of ICD leads with an increase in the pacing threshold ratio measured between the Pre-MRI and 1-month post-MRI
Serious Adverse Device Effect (SADE)-free rate of implantable cardioverter defibrillators and leads possibly or securely related to the MRI procedure
时间窗: 1 Month
次要结局
未报告次要终点