Advisa MRI™ System Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 269
- 试验地点
- 54
- 主要终点
- Magnetic Resonance Imaging (MRI)-Related Complications
研究概览
简要总结
The purpose of the Advisa MRI System clinical study is to confirm safety and effectiveness in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur anywhere on the body including the chest).
详细描述
The Advisa MRI IPG is a dual chamber, multi-programmable IPG. The IPG is indicated to restore heart rates, improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders. The IPG is indicated for use in patients who may benefit from rate-responsive pacing to support cardiac output during varying levels of activity and has been modified for use during an MRI exam.
Subjects will have required follow-up visits after implant, at 2 months, 9-12 weeks, 3 months, 4 months, 6 months and every 6 months thereafter until the study ends. The MR scans will occur at the 9-12 weeks visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 a Class I or II indication for implantation of a dual chamber pacemaker according to the American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines
- •Subjects who are able to undergo a pectoral implant
- •Subjects who are able and willing to undergo elective magnetic resonance (MR) scanning without sedation
- •Subjects who are geographically stable and available for follow-up at the study center 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 1.0 milligram (mg) dexamethasone acetate may be contraindicated
- •Subjects who require a legally authorized representative to obtain consent
- •Subjects who have a previously implanted pacemaker or implantable cardioverter defibrillator (ICD) (abandoned pacemaker and/or defibrillator leads are not permitted; however subjects with complete system explants are not excluded)
- •Subjects who are immediate candidates for an ICD
- •Subjects who require an indicated MR scan, other than those specifically described in the study, before the 4 months follow-up
- •Subjects with previously implanted active medical devices
- •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)
研究组 & 干预措施
MRI group
Subjects randomized to the MRI group will undergo a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
干预措施: Medtronic Advisa MRI Implantable Pulse Generator (IPG) (Device)
MRI group
Subjects randomized to the MRI group will undergo a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
干预措施: Medtronic CapSureFix MRI™ active fixation MRI lead (Device)
Control group
Subjects randomized to the Control group will wait for one hour without having any MRI scan at 9-12 weeks post-implant.
干预措施: Medtronic Advisa MRI Implantable Pulse Generator (IPG) (Device)
Control group
Subjects randomized to the Control group will wait for one hour without having any MRI scan at 9-12 weeks post-implant.
干预措施: Medtronic CapSureFix MRI™ active fixation MRI lead (Device)
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
For each subject in this objective, the endpoint was the occurrence of an MRI-related complication within 30 days post-MRI. An independent Adverse Event Advisory Committee (AEAC) determined whether each adverse event was a complication and whether it was MRI-related.
Atrial Pacing Capture Threshold Success
时间窗: Pre-MRI/waiting period 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.
Ventricular Pacing Capture Threshold Success
时间窗: Pre-MRI /waiting period to 1-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
- System-related Complications(Implant to four months post implant)
- Ventricular Sensed Amplitude Success(Pre-MRI /waiting period to 1-month post-MRI/waiting period)
- Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.(During MRI scans)
- Atrial Sensed Amplitude Success(Pre-MRI /waiting period to 1-month post-MRI/waiting period)