Accent Magnetic Resonance Imaging Pacemaker and Tendril Magnetic Resonance Imaging™ Lead Investigational Device Exemption Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 950
- 试验地点
- 70
- 主要终点
- Freedom From Right Ventricular (RV) Lead-related Complications in the Acute Time Period
研究概览
简要总结
The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI™ System in a patient population indicated for implant of a pacemaker within and outside of the MRI environment.
详细描述
The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI System in a patient population indicated for implant of a pacemaker within and outside of the MRI environment. The study consisted of two phases, a Lead Safety Phase which evaluated the safety of the Tendril MRI lead, and an MRI Phase which evaluated the safety and efficacy of the Accent MRI pacemaker system in an MRI environment.
The safety and efficacy of the Accent MRI pacemaker and Tendril MRI lead will be evaluated as described below:
Lead Safety Safety of the Tendril MRI™ lead will be evaluated in terms of freedom from right atrial (RA) and right ventricle (RV) lead-related complications at implant to 2 months (acute timeframe), and at the 2 through the 12 month visit (chronic timeframe).
MRI Safety The safety of the Accent MRI™ system will be evaluated in terms of freedom from MRI scan related complications in the month following the MRI scan.
Lead Efficacy Efficacy of the Tendril MRI™ lead will be evaluated in terms of the change in atrial and ventricular capture and sensing thresholds before and after the MRI scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Eligible patients will meet all of the following:
- •Have an approved indication per American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines for implantation of a pacemaker
- •Will receive a new pacemaker and lead
- •Be willing to undergo an elective MRI scan without sedation
- •Be able to provide informed consent for study participation (legal guardian is NOT acceptable)
- •Be willing and able to comply with the prescribed follow-up tests and schedule of evaluations
- •Is not contraindicated for an MRI scan (per the pre-MRI safety screening form)
排除标准
- •Patients will be excluded if they meet any of the following:
- •Are medically indicated for an MRI scan at the time of enrollment
- •Have an existing pacemaker or implantable cardioverter defibrillator (ICD). A new pacemaker and lead is required for enrollment
- •Have an existing active/inactive implanted medical device, e.g., neurostimulator, infusion pump, etc.
- •Have a non-MRI compatible device or material implanted (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.)
- •Have a lead extender or adaptor
- •Be unable to fit in MRI bore; will come into contact with the magnet façade inside the MRI bore.
- •Have a prosthetic tricuspid heart valve
- •Are currently participating in a clinical investigation that includes an active treatment arm
- •Are allergic to dexamethasone sodium phosphate (DSP)
- •Are pregnant or planning to become pregnant during the duration of the study
- •Have a life expectancy of less than 12 months due to any condition
- •Patients with exclusion criteria required by local law (e.g., age)
- •Are unable to comply with the follow up schedule
研究组 & 干预措施
Lead Safety
Patient implanted with an Accent MRI system to evaluate safety of the Tendril MRI lead
干预措施: Accent MRI system (lead safety) (Device)
Accent MRI system MRI Scan Group
Patient implanted with an Accent MRI system will receive an MRI scan to evaluate safety and efficacy of the Accent MRI system in an MRI environment
干预措施: Accent MRI system (with MRI scan) (Device)
结局指标
主要结局
Freedom From Right Ventricular (RV) Lead-related Complications in the Acute Time Period
时间窗: Implant through 2 months
Percentage of patients who do not have RV lead-related complications from implant through the 2 month study visit
Freedom From MRI Scan-related Complications
时间窗: MRI Scan visit through 1 month after MRI scan visit
Percentage of patients who do not have MRI-related complications from the MRI scan visit to the 1 month post MRI scan visit
Change in Atrial Capture Threshold From Pre to Post MRI Scan
时间窗: MRI Scan visit to 1 month after MRI scan visit
Percentage of patients with an increase in RA capture thresholds of \<= 0.5 V, at a pulse width of 0.5 ms .
Change in Ventricular Sense Amplitude
时间窗: MRI Scan visit to 1 month after the MRI Scan visit
Percentage of patients with an reduction in RV sense amplitude \<=50% and sense amplitude \>=5 mV.
Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period
时间窗: Implant through 2 months
Percentage of patients who do not have RA lead-related complications from implant through the 2 month study visit
Freedom From RA Related Complications in the Chronic Period
时间窗: 2 months through 12 months
Percentage of patients who do not have RA lead-related complications from the 2 month through the 12 month study visit
Freedom From Right Ventricular Lead Related Complications in the Chronic Period
时间窗: 2 months through 12 months
Percentage of patients who do not have RV lead-related complications from the 2 month through the 12 month study visit
Change in Atrial Sense Amplitude
时间窗: MRI Scan visit to 1 month after MRI scan visit
Percentage of patients with a reduction in RA sense amplitude \<=50 % and sense amplitude \>=1.5 mV.
Change in Ventricular Capture Threshold Pre to Post MRI Scan
时间窗: MRI Scan visit to 1 month after MRI scan visit
Percentage of patients with an increase in RV capture thresholds of \<=0.5V, at a pulse width of 0.5 ms.
次要结局
- Ventricular Capture Threshold at the MRI Visit(MRI Scan visit (approx 3 months post implant))
- Freedom From System-related Complications(Implant through 12 months)
- Atrial Capture Threshold at the MRI Visit(MRI Scan visit (approx 3 months post implant))