The Evaluation of ICD Defibrillation Systems in a 1.5T Magnetic Resonance Imaging Environment in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Participants With Freedom From Magnetic Resonance Imaging (MRI) Scan Related Complications
研究概览
简要总结
This clinical study is to evaluate the safety and effectiveness of the Ellipse VR/DR implantable cardiac defibrillators (ICDs) and the Quadra Assura MP cardiac resynchronization therapy defibrillators (CRT-Ds), with Durata or Optisure defibrillation leads, Tendril STS or Isoflex pacing leads, and the Quartet quadripolar leads in a 1.5T MRI environment for MR-conditional labeling expansion of these market-approved ICD/CRT-D systems in China.
Note: Protocol updated: Fortify Assura VR/DR ICD removed; Quadra Assura MP CRT-D and Quartet leads added. The Detailed Description Section below was updated upon protocol amendment.
详细描述
Endpoints, and contents of clinical study
Objectives:
The objective of this clinical study is to evaluate the safety and effectiveness of the Ellipse VR/DR implantable cardiac defibrillators (ICDs) and the Quadra Assura MP cardiac resynchronization therapy defibrillators (CRT-Ds), with Durata or Optisure defibrillation leads, Tendril STS or Isoflex pacing leads, and the Quartet quadripolar leads in a 1.5T MRI environment for MR-conditional labeling expansion of these market-approved ICD/CRT-D systems in China.
There are four device combination groups in this clinical study as outlined below:
- Group 1: Ellipse VR single-chamber ICD with a Durata lead in the right ventricle (RV).
- Group 2: Ellipse DR dual-chamber ICD, with a Durata lead in the RV and a Tendril STS lead in the right atrium (RA).
- Group 3: Ellipse DR dual-chamber ICD with a Optisure lead in the RV and a Isoflex lead in the RA.
- Group 4: Quadra Assura MP CRT-D with a Durata or Optisure lead in the RV, a Tendril STS or Isoflex lead in the RA, and a Quartet lead in the left ventricle (LV).
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
- •To participate in this clinical study, the subject must meet all of the following inclusion criteria:
- •Have an approved indication for implantation of a ICD
- •Be a Chinese national
- •Will be implanted with one of the following device/lead combinations evaluated in this study:
- •Group 1: Ellipse VR single-chamber ICD with a Durata lead in the right ventricle (RV)
- •Group 2: Fortify Assura single-chamber ICD, with an Optisure lead
- •Group 3: Ellipse DR dual-chamber ICD with a Durata lead in the RV and a Tendril STS lead in the right atrium (RA)
- •Group 4: Fortify Assura ICD and an Optisure lead in the RV and an Isoflex lead in the RA
- •Be willing to undergo an elective MRI scan without sedation ≥ 45 days after implant NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the patient can communicate with site personnel during the MRI scan
- •Be able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable)
- •Be willing and able to comply with the prescribed follow-up tests and procedures
- •Are not contraindicated for an MRI scan (per the MRI Screening Form)
- •Subjects who are at least 18 years of age (or older, required by local law)
排除标准
- •Subjects who meet any of the following exclusion criteria must be excluded from the clinical investigation:
- •Have a competitor's MRI compatible endocardial lead implanted or capped
- •Have another existing active implanted medical device, e.g., neurostimulator, infusion pump, etc. that has MR labeling that will not allow the MRI scans per this protocol to be completed.
- •Have other non-MRI compatible device or material implanted. The following examples may be included as long as labelling of these devices allow MRI scans conducted per this protocol:
- •MRI compatible knee replacements, hip replacements, stents, etc.
- •MRI compatible mechanical, prosthetic, and bio prosthetic heart valves
- •Non-removable dental implants
- •Have a lead extender, adaptor, or capped/abandoned lead
- •Enrolled or intend to participate in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug or additional testing beyond standard of care procedures), which could confound the results of this study as determined by Abbott.
- •Pregnant or planning to become pregnant during the duration of the subject's participation in the study
- •Have a life expectancy of less than 12 months due to any condition
结局指标
主要结局
Number of Participants With Freedom From Magnetic Resonance Imaging (MRI) Scan Related Complications
时间窗: 1 month from MRI scan
Freedom from Magnetic Resonance Imaging (MRI) scan related complications related to the Implantable Cardiac Difibrillator (ICD) device and/or leads from the time of the MRI scan to 1-month post-MRI scan testing.
Effectiveness Outcomes: Percentage of Leads With a Capture Threshold Increase
时间窗: pre-MRI scan to 1 month post-MRI scan
Proportion of leads with a capture threshold increase of ≤ 0.5V at 0.5ms from pre-MRI scan to 1-month post-MRI scan testing.
The Percentage of Leads With a Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan Testing to 1-month Post-MRI Scan.
时间窗: pre-MRI scan to 1 month post-MRI scan
Proportion of subjects with a sensing amplitude decrease ≤ 50% from pre-MRI scan to 1-month post MRI scan % (n/N)
次要结局
- Number of Participants With Whole Body (WB) SAR Values Measured ≥ 1.8 W/kg(during MRI scan)
- Summary of Subjects That Returned to Usual Programming(MRI scan visit)
- Device Electrical Measurements(Pre-MRI scan, Post MRI scan, 1 month follow-up)