CapSureFix® Novus Model 5076 Lead MRI Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 266
- 试验地点
- 68
- 主要终点
- Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Atrial Voltage Thresholds
研究概览
简要总结
The purpose of this study is to test the safety and effectiveness of the Medtronic CapSureFix Novus Model 5076 lead when patients are implanted with the Medtronic Advisa MRI pacemaker and undergo an MRI scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have Class I and II indication for implantation of a dual chamber pacemaker according to the ACC/AHA/HRS guidelines
- •Subjects who are able to undergo a pectoral implant
- •Subjects who:
- •are receiving an IPG for the first time, OR
- •are receiving a replacement IPG connected to two previously- implanted (atrial and ventricular) Model 5076 leads
- •Subjects who are able and willing to undergo elective MRI scanning without sedation
- •Subjects who are geographically stable and available for follow-up at the study site for the length of the study
排除标准
- •Subjects with a mechanical tricuspid heart valve.
- •Subjects with a history of significant tricuspid valvular disease.
- •Subjects for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated.
- •Subjects who require a legally authorized representative to obtain consent.
- •Subjects who have abandoned (inactive) pacemaker and/or defibrillator leads
- •Subjects who are immediate candidates for an ICD.
- •Subjects who require an indicated MRI scan, other than those specifically described in the study, before the one-month post MRI/waiting period follow-up.
- •Subjects with previously implanted active medical devices (exception Model 5076 Lead and Advisa MRI IPG).
- •Subjects with a non-MRI compatible device (such as ICDs or neurostimulators) or material implant (e.g., non-MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys).
- •Subjects with medical conditions that preclude the testing required by the protocol or limit study participation.
- •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 this clinical study.
- •Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control.
- •Subjects with exclusion criteria required by local law (e.g., age, breastfeeding).
结局指标
主要结局
Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Atrial Voltage Thresholds
时间窗: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period
Subjects' atrial pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.
MRI-related Complication Free Rate
时间窗: MRI scan to one month later
Number of patients free of MRI-related complications
Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Ventricular Voltage Thresholds
时间窗: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period
Subjects' ventricular pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.
次要结局
- Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Ventricular Sensing Amplitude(Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period)
- Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Atrial Sensing Amplitude(Pre-MRI /waiting period (9-12 weeks post-implant) to 1-month post-MRI/waiting period)
- Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.(During MRI scans (9-12 weeks post-implant))