EnRhythm MRI™ SureScan™ Pacing System Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 484
- 试验地点
- 45
- 主要终点
- Magnetic Resonance Imaging (MRI)-Related Complications
研究概览
简要总结
The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing System (used in support of Revo MRI™ SureScan Pacing System launch).
详细描述
This study is a prospective, multi-center global study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has, or is at risk of having, a heart beat that is too slow and his/her doctor has determined he/she needs a pacemaker.
- •Subject available for follow-up at study center for length of study.
- •Subject able and willing to undergo elective MRI scanning without sedation.
排除标准
- •Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD).
- •Subject needs or will need another MRI-scan, other than those required by the study, during the required study follow-up period.
- •Pregnant women, or women of child bearing potential who are not on a reliable form of birth control.
- •Subject with exclusion criteria required by local law.
- •Subject who intends to participate in another clinical study during this clinical study.
结局指标
主要结局
Magnetic Resonance Imaging (MRI)-Related Complications
时间窗: MRI scan to one-month post-MRI scan
Subjects with a complication related to the MRI scan. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the MRI scan.
Atrial Pacing Capture Threshold Success
时间窗: 9-12 week visit to 4-month visit
Subjects' atrial pacing capture threshold (the energy sent from the pacemaker needed to make the heart's atrium beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more.
Ventricular Pacing Capture Threshold Success
时间窗: 9-12 week visit to 4-month visit
Subjects' ventricular pacing capture threshold (the energy sent from the pacemaker needed to make the heart's ventricle beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more.
Atrial Sensed Amplitude Success
时间窗: 9-12 week visit to 4-month visit
Subjects' atrial sensed amplitude (the minimum energy produced by the heart's atrium that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 1.5 millivolts (mV).
Ventricular Sensed Amplitude Success
时间窗: 9-12 week visit to 4-month visit
Subjects' ventricular sensed amplitude (the minimum energy produced by the heart's ventricle that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 5.0 millivolts (mV).
次要结局
- Occurrence of Arrhythmias(During the MRI scan)
- Atrial Lead Impedance Change(9-12 week visit and 4-month visit)
- Ventricular Lead Impedance Change(9-12 week visit and 4-month visit)
- Atrial Lead Handling Rating(During implant)
- Ventricular Lead Handling Rating(During implant)
- Atrial Pacing Capture Threshold(3 or 4 months post-implant)
- Ventricular Pacing Capture Threshold(3 or 4 months post-implant)
- Atrial Sensed Amplitude(3 or 4 months post-implant)
- Ventricular Sensed Amplitude(3 or 4 months post-implant)
- Subjects With System-related Complications(Implant to 4 Months)
- System Related Adverse Device Effects Due to Labeling Instructions(Implant through 18 months post-implant)