jRCT2052220049已完成不适用
Aveir Dual-Chamber Leadless i2i IDE Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 550
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Subject must have at least one of the clinical indications before device implant in adherence with ACC/AHA/HRS/ESC dual chamber pacing guidelines
- •Subject is 18 and over years of age or age of legal consent, whichever age is greater
- •Subject has a life expectancy of at least one year
- •Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
- •Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC
排除标准
- •Subject is currently participating in another clinical investigation that may confound the results of this study as determined by the Sponsor
- •Subject is pregnant or nursing and those who plan pregnancy during the clinical investigation follow-up period
- •Subject has presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigators opinion, could confound the assessment of the investigational device and/or implant procedure, limit the subjects ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results
- •Subject has a known allergy or hypersensitivity to less than 1 mg of dexamethasone sodium phosphate or any blood or tissue contacting material listed in the IFU
- •Subject has an implanted vena cava filter or mechanical tricuspid valve prosthesis
- •Subject has pre-existing, permanent endocardial pacing or defibrillation leads (does not include lead fragments)
- •Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
- •Subject has an implanted leadless cardiac pacemaker (except for an Aveir ventricular LP)
- •Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators)*
- •Subject is unable to read or write
- •NOTE: Does not apply to a medical device with no known impact to the Aveir Leadless Pacemaker System, including the Aveir Link Module. Patient evaluation and the decision to implant the LP should take into account the presence of other active implantable devices and should include consultation with the Sponsor and/or manufacturer of the co-existing device.
结局指标
主要结局
Primary Safety Endpoint
时间窗: 3-month
The primary safety endpoint evaluates the 3-month Aveir DR LP system Complication Free Rate (CFR) in de novo subjects based on CEC adjudication of adverse events.
Primary Effectiveness Endpoint#1
时间窗: 3-month
The primary effectiveness endpoint #1 evaluates the 3-month composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects.
Primary Effectiveness Endpoint#2
时间窗: 3-month
The primary effectiveness endpoint #2 evaluates the 3-month AV-synchrony success rate at rest while seated in de novo subjects.
次要结局
- Aveir Atrial LP complication free rate (CFR) at 3-months post-implant(3-months post-implant)
研究者
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