Master Study for the MRI Compatibility of the Solia S and Solia T Pacing Lead, the Linoxsmart ProMRI and Linoxsmart ProMRI DF4 ICD (Implantable Cardioverter-defibrillator) Lead and the Corox ProMRI OTW Coronary Sinus Lead in Combination With the Ilesto/Iforia ICD or the Evia/Entovis Triple Chamber Pacemaker
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 23
- 主要终点
- The Serious Adverse Device Effect (SADE) -free rate of the ICD/CRT-P system related to MRI
研究概览
简要总结
This investigation is designed to provide supporting evidence for the clinical safety of the Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T (Heart Failure) triple chamber pacemaker system when used under specific MRI (magnetic resonance imaging) 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
- •Written informed consent
- •Able and willing to complete MRI testing
- •Able and willing to activate and use the Cardio Messenger
- •Able and willing to complete all testing required by the clinical protocol
- •Available for all follow-up visits at the investigational site
- •Standard indication for single, dual, or triple chamber ICD or CRT-P.
- •ICD or CRT-P system to be implanted in the pectoral region
- •Patient body height ≥ 140 cm
- •Age ≥ 18 years
排除标准
- •Standard contraindication for single, dual, or triple chamber ICD or CRT-P.
- •Systems with an atrial lead: The patient has persistent (lasting longer than 7 days or requiring cardioversion) or permanent atrial arrhythmia
- •Patient has other medical implants that may interact with MRI, e.g. abandoned pacemaker/ICD leads, lead extensions, mechanical valves, other active medical devices, non-MRI compatible devices
- •Patient has other metallic artifacts / components in body that may interact with MRI
- •Life expectancy of less than eight months
- •Cardiac surgery in the next eight months
- •Pregnant or breastfeeding
- •Enrolled in another non-observational cardiac clinical investigation
结局指标
主要结局
The Serious Adverse Device Effect (SADE) -free rate of the ICD/CRT-P system related to MRI
时间窗: pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI
Decrease in P-wave and R-wave amplitude (right and left) between pre-MRI and 1-month post-MRI.
时间窗: pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI
Increase in atrial and ventricular pacing threshold(s) between pre-MRI and 1-month post-MRI
时间窗: pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI
次要结局
未报告次要终点