Aveir Dual-Chamber Leadless i2i IDE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 464
- 试验地点
- 145
- 主要终点
- Percentage of Participants Free From Aveir DR System-Related Complications at 3-months
研究概览
简要总结
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
详细描述
The purpose of this clinical investigation is to evaluate the clinical safety and effectiveness of the Aveir DR Leadless Pacemaker system in a patient population indicated for a DDD(R) pacemaker.
Subjects participating in the study are followed through at least 12 months with data collected at baseline, implant procedure, pre (hospital) discharge, and follow-up at 1 month, 3 months, 6 months, 12 months, and every 6 months thereafter until study completion
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •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 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 investigator's opinion, could confound the assessment of the investigational device and/or implant procedure, limit the subject's 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 < 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 leadless pacemaker)
- •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
研究组 & 干预措施
Single Arm
Non randomized arm
干预措施: Aveir DR Leadless Pacemaker System (Device)
结局指标
主要结局
Percentage of Participants Free From Aveir DR System-Related Complications at 3-months
时间窗: 3 months
Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects. A complication was defined as a device-or-procedure-related serious adverse event. Complications included Atrial LP, Ventricular LP, and implant procedure-related complications. Complications possibly related or related to COVID-19 were excluded.
Percentage of Participants Free From Aveir DR System-Related Complications at 12-months
时间窗: 12 months
Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects. A complication was defined as a device-or-procedure-related serious adverse event. Complications included Atrial LP, Ventricular LP, and implant procedure-related complications. Complications possibly related or related to COVID-19 were excluded.
Percentage of Subjects With Acceptable Atrial Threshold and Amplitude Measurements at 3-months
时间窗: 3 months
Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects. A subject was considered to have met the primary effectiveness endpoint #1 if the pacing threshold voltage was ≤ 3.0 V at 0.4 ms at the 3-month visit and the sensed P-wave amplitude was ≥ 1.0 mV at the 3-month visit.
Percentage of Subjects With Acceptable Atrial Threshold and Amplitude Measurements at 12-months
时间窗: 12 months
Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects. A subject was considered to have met the success criteria for the endpoint if the pacing threshold voltage was ≤ 3.0 V at 0.4 ms at the 12-month visit and the sensed P-wave amplitude was ≥ 1.0 mV at the 12-month visit.
Percentage of Participants With AV Synchrony Success Rate at Rest While Seated
时间窗: 3 months
AV synchrony success was defined as subjects with a paced or sensed ventricular beat within 300 ms following a paced or sensed atrial beat (i.e., a synchronous cycle) for at least 70% of evaluable cardiac cycles.
次要结局
- Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 12-months(12 months)
- Slope of the Normalized Increase in the Sensor Indicated Rate Versus Normalized Workload of the Aveir Atrial Leadless Pacemaker During Exercise Testing(3 months)
- Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 3-months(3 months)