Expanding MRI (Magnetic Resonance Imaging) Access for Patients With New and Existing ICDs (Implantable Cardioverter Defibrillator) and CRT-Ds (Cardiac Resynchronization Therapy Defibrillator)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 58
- 主要终点
- Percentage of Participants Free From MR (Magnetic Resonance) Scan-related Complications
研究概览
简要总结
The objective of this study is to collect data to confirm the safety and effectiveness of the Image Ready™ MR (Magnetic Resonance) Conditional Defibrillation System when used in the 1.5T (Tesla) MRI environment under the labeled Conditions of Use (Phase I).
Additionally, the study will assess medically necessary MR scans according to the labeled Conditions of Use to provide real-world scanning data (Phase I and Phase II).The study also aims to demonstrate the continued ability of the ImageReady MR Conditional Defibrillation System to sense and detect ventricular fibrillation (VF) post MRI scan by collecting and analyzing data from spontaneous VF episodes, "for-cause" VF inductions, and from an optional VF induction Sub-study.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Phase I: Subject is indicated per guidelines and will receive a CRT-D or ICD system OR Subject is implanted with a functional and stable CRT-D or ICD system Phase II: Subject is implanted with a functional and stable CRT-D or ICD system
- •Subject will receive or is implanted with an ICD or CRT-D pulse generator in the left or right pectoral region
- •Subject is able and willing to undergo an MR scan without intravenous sedation (Phase I only)
- •Subject is willing and capable of providing informed consent and participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
- •Subject is age 18 or above, or of legal age to give informed consent specific to state and national law
排除标准
- •Subject implanted with an ICD or CRT-D pulse generator with battery at Explant status
- •Subject has other active or abandoned implanted cardiac rhythm devices, components or accessories present such as pulse generators, leads, lead adaptors or extenders
- •Presence of metallic objects that represent a contraindication to MR imaging at the discretion of the Radiologist and impacting the ability to conduct the study protocol
- •Subject needs or will need a medically necessary MR scan, before completing the 1-month post-MR follow-up visit (Phase I only)
- •Subject with:
- •A history of syncope related to brady-arrhythmia
- •A history of syncope of unknown etiology
- •Sinus pauses (Pause > 2 s)
- •Permanent or intermittent complete AV (Atrioventricular ) block
- •Documentation of progressive AV nodal block over time
- •Trifascicular block (alternating bundle branch block or PR > 200 ms (interval between P wave and R-wave) with LBBB ( Left bundle branch block) or other bifascicular block) Note: It is required to run a 12 lead ECG (Electrocardiography) and a 10s rhythm strip to document this exclusion criterion. During ECG acquisition, subjects must be in either their own intrinsic rhythm or, in subjects with an existing device implant, the device must be programmed to VVI (ventricular demand pacing) 40 ppm.
- •Subject is not clinically capable of tolerating the absence of pacing or Resynchronization therapy support in a supine position for the duration that the pulse generator is in MRI Protection Mode, per Physician discretion
- •Subject is not clinically capable of tolerating the absence of Tachycardia therapy support for the duration that the pulse generator is in MRI Protection Mode, per Physician discretion
- •Subjects with a planned RA( right atrium), RV ( right ventricle) or LV (left ventricle) lead revision or extraction within 30 days of enrollment (Phase I only)
- •Subjects with an implanted lead that is planned to be extracted during the study implant procedure
- •Subjects currently requiring dialysis
- •Subject has a mechanical heart valve
- •Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)
- •Subject is currently on the active heart transplant list
- •Subject has documented life expectancy of less than 12 months
- •Subject is enrolled in a concurrent study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific
- •Women of childbearing potential who are or might be pregnant, and will receive an ICD or CRT-D pulse generator
- •VF Induction Sub-study Exclusion Criteria:
- •In addition to meeting all of the inclusion criteria and none of the exclusion criteria of the ENABLE MRI study, subjects enrolled in the VF Induction Sub-study must also not meet any of the following VF Induction Sub-study exclusion criteria:
- •Unstable heart failure requiring hospitalization in the last 30 calendar days
- •Unable to tolerate sedation (e.g. IV (intravenous sedation )sedation, general anesthesia)
- •Planned cardiac revascularization procedure
- •Right Ventricular Lead R wave is less than 5 mV(milliVolt)
结局指标
主要结局
Percentage of Participants Free From MR (Magnetic Resonance) Scan-related Complications
时间窗: The time between the MR Scan and MRI + 1 Month
MR scan-related CFR (Complication-free rate) between the MR Scan and the MRI + 1 (Magnetic Resonance Imaging) Month Visit
Percentage of Participants That Had an Increase in Average LV ( Left Ventricle) Pacing Threshold ≤ 1.0V (Volt) at 0.5 ms.
时间窗: The time between the MR Scan and MRI + 1 Month
Increases in average LV pacing threshold (at 0.5 ms) pre- MR scan and 1 Month post-MR scan were calculated for subjects. Subjects that had an increase in pacing thresholds measurements ≤ 1.0V (at 0.5 ms) from pre-MR Scan at MRI Visit to MRI + 1 Month Visit were considered a success.
Percentage of Participants That Had a Decrease in RV ( Right Ventricle) Sensed Amplitude
时间窗: The time between the MR Scan and MRI + 1 Month
Decreases in RV sensed amplitude pre-MR scan and 1 Month post-MR scan were calculated for subjects. Subjects were considered a success if the average sensed amplitude at the MRI + 1 Month Visit remains ≥ 5.0 mV and above 50% of the pre-MR scan value. Subjects who had an average pre-scan RV sensed amplitude measurement \< 5.0 mV were excluded from this analysis.
Percentage of Participants That Had an Increase in Average Pacing Thresholds ≤ 0.5V (Volt) (at 0.5 ms) in the RV
时间窗: The time between the MR Scan and MRI + 1 Month
Increases in RV pacing threshold (at 0.5 ms) pre- MR scan and 1 Month post-MR scan were calculated for subjects. Subjects that had an increase in average pacing thresholds ≤ 0.5V (at 0.5 ms) from pre-MR Scan to MRI Visit + 1 Month follow-up were considered a success.
Percentage of Participants That Decrease in LV ( Left Ventricle) Sensed Amplitude
时间窗: The time between the MR Scan and MRI + 1 Month
Decreases in average LV sensed amplitude pre-MR scan and 1 Month post-MR scan were calculated for subjects. Subjects were considered a success if the average sensed amplitude at the MRI + 1 Month Visit remained ≥ 5.0 mV and above 50% of the average pre-MR scan value. Subjects who had an average pre-scan LV sensed amplitude measurement \< 5.0 mV were excluded from this analysis.
次要结局
未报告次要终点