Clinical Investigation of ENO/TEO/OTO Pacing System Under MRI Environment
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Freedom from MRI-related complications following the MRI scan of the ENO/TEO/OTO pacing system
研究概览
简要总结
The interest of the CAPRI study is to confirm the safety and the efficacy of the ENO/TEO/OTO pacing system when used under 1.5 or 3 Tesla MRI environment and in accordance with the MRI solutions guideline.
详细描述
The purpose of CAPRI study is to confirm the safety and the efficacy of the CE marked MR conditional pacing system composed of the ENO, TEO or OTO pacemaker with VEGA pacing lead(s). Conditions to undergo an MRI scan are provided in the MRI solutions guideline.
The primary objective is to confirm the clinical safety of the ENO/TEO/OTO pacing system when used under 1.5 and 3 Tesla specific MRI conditions without scan exclusion zone.
The study secondary main objectives are aiming to assess the performance of the MR conditional pacing system in the right atrium and ventricle at 1 month following the MRI scan:
- Stability of the Pacing Capture Threshold
- Stability of the lead sensed amplitude
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •Subjects who meet all the following criteria at the time of inclusion visit may be included:
- •Already implanted in the left or right pectoral region for at least 6 weeks with:
- •ENO, TEO or OTO single chamber rate response (SR) pacemaker with a VEGA pacing lead, or
- •ENO, TEO or OTO dual chamber rate response (DR) pacemaker with two VEGA pacing leads.
- •Implanted pacing system must fulfill the following parameters:
- •Battery impedance is < 5 Kilo Ohm (kΩ)
- •Pacing capture threshold value is ≤ 2 Volts (V) at 0.35 millisecond (ms)
- •Lead impedance value between 200Ω and 3000Ω
- •No diaphragmatic or pectoral stimulation at 5V/1ms
- •P-wave minimum sensed amplitude ≥ 1mV for patients with sinus rhythm
- •R-wave minimum sensed amplitude ≥ 4mV for patients with spontaneous conduction rhythm
- •Must agree to undergo a non clinically-indicated MRI scan without intravenous injection and without sedation;
- •Have reviewed, signed and dated informed consent.
- •Subjects who meet any of the following criteria are not eligible to be included in the study:
- •Included in another clinical study that could confound the results of this study such as studies involving intra-cardiac device;
- •Have other active or abandoned cardiac implants already implanted;
- •Have other active or passive non MR conditional devices implanted such as metallic foreign body;
- •Have a history of brain aneurysm with ferromagnetic clipping;
- •Have a planned cardiac surgery within the 3 months of inclusion;
- •Have a medical MRI examination prescription planned within the 3 months of inclusion;
- •Age less than 18 years old or under guardianship or kept in detention;
- •Known pregnancy, women breastfeeding or in childbearing age without an adequate contraceptive method ;
- •Be unavailable for the scheduled follow-up associated with this clinical study or refusal to cooperate.
排除标准
- 未提供
结局指标
主要结局
Freedom from MRI-related complications following the MRI scan of the ENO/TEO/OTO pacing system
时间窗: 1 month post MRI
An MRI-related complication is defined as a Serious Adverse Event (SAE) that led to death or to an invasive intervention or a Device Deficiency that causes the termination of any significant device function per Clinical Event Committee (CEC) adjudication. The primary endpoint will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).
次要结局
- Atrial Pacing Capture Threshold stability in the right atrium and ventricle following the MRI scan(1 month post MRI)
- Ventricular Pacing Capture Threshold (PCT) stability in the right atrium and ventricle following the MRI scan(1 month post MRI)
- Ventricular sensed amplitude stability in the right atrium and ventricle following the MRI scan(1 month post MRI)
- Atrial sensed amplitude stability in the right atrium and ventricle following the MRI scan(1 month post MRI)