ProMRI Study of the Entovis Pacemaker System (Phase B)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 221
- 主要终点
- MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate
研究概览
简要总结
The objective of the ProMRI Study (Phase B) is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions without scan exclusion zone.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The following initial inclusion criteria must be met for a subject to be enrolled and considered for the MRI-procedure:
- •Age greater than 18 years
- •Able and willing to complete MRI testing
- •Able to provide written informed consent
- •Available for follow-up visit at the study site
- •Implanted with a pacemaker system consisting only of an Entovis pacemaker (DR-T, SR-T) and one or two Setrox S 53 or Setrox S 60 pacemaker lead(s). (No leads other than Setrox S (53 or 60 cm) leads may be implanted. This includes lead extensions or abandoned leads in the subject.)
- •Pacemaker implanted pectorally
- •All pacemaker system components implanted, repositioned, or exchanged at least 5 weeks prior to enrollment
- •Underling rhythm identifiable during sensing test
- •All pacing thresholds are measureable and are less than or equal to 2.0 V @0.4 ms
- •Absence of phrenic nerve stimulation at 4.8V @ 1.0 ms
- •Pacing impedance is between 200 and 1500 ohm
- •Able and willing to use the Cardio Messenger
- •At the pre-MRI procedure, the following procedure-related criteria must be met for the subject to undergo the MRI scan:
- •Absence of phrenic nerve stimulation at 4.8V @ 1.0 ms
- •|pacing threshold at Pre-MRI follow-up - pacing threshold at baseline| ≤ 0.5 V
- •All pacing thresholds are measureable and are ≤ 2.0 V @ 0.4 ms
- •The pacemaker system has been implanted for at least 6 weeks.
- •Subject did not have a pacemaker or lead explant, exchange or reposition in the previous 6 weeks.
- •All lead impedances are between 200 and 1500 ohm.
- •Battery status is at least 30% of capacity
排除标准
- •Enrolled in any other clinical study
- •For pacemaker systems that include an atrial lead, subjects with either
- •Persistent atrial arrhythmia (lasting longer than 7 days or requiring cardioversion)
- •Permanent atrial arrhythmia
- •Life expectancy of less than three months
- •Pregnancy
- •Cardiac surgery expected in the next three months
- •Implanted with other medical devices that may interact with MRI, such as:
- •abandoned pacemaker/ICD leads
- •lead extensions
- •mechanical valves
- •other active medical devices
- •non-MRI compatible devices
- •other metallic artifacts/components in body that may interact with MRI
结局指标
主要结局
MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate
时间窗: 1 Month Post-MRI
Percentage of Participants Free of Atrial Pacing Threshold Rise
时间窗: Between Pre-MRI and 1 Month Post-MRI
Evaluate the percentage of atrial pacing leads with a pacing threshold increaess between the Pre-MRI and one-month post-MRI follow-up.
Percentage of Participants Free of Ventricular Pacing Threshold Rise
时间窗: Between Pre-MRI and 1 Month Post-MRI
Evaluate the percentage of ventricular pacing leads with a pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.
Percentage of Participants Free of P-wave Sensing Attenuation
时间窗: Between Pre-MRI and 1 Month Post-MRI
Evaluate the percentage of subjects who experience P-wave attenuation between the pre-MRI and one-month post-MRI follow-up.
Percentage of Participants Free of R-wave Sensing Attenuation
时间窗: Between Pre-MRI and 1 Month Post-MRI
Evaluate the percentage of subjects who experience R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.
次要结局
未报告次要终点