LEadless Advanced Pacing 2 Chronic Early Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of Participants Free From AVEIR CSP related Complications at 1-month
研究概览
简要总结
Prospective, single-arm, non-randomized, unblinded, chronic feasibility study designed to evaluate the safety and performance of the AVEIR™ Conduction System Pacing (CSP) Leadless Pacemaker system.
详细描述
The purpose of this clinical investigation is to evaluate the chronic safety and performance of the AVEIR CSP Leadless Pacemaker system in a patient population with standard pacing indications.
Subjects participating in the study will have data collected at baseline, implant procedure, pre (hospital) discharge, and follow-up at 1 month, 2 months, 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 standard pacemaker indication
- •Subject must be at least 18 years of age
- •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, as approved by the local EC
排除标准
- •Subject has a mechanical tricuspid valve, percutaneous tricuspid valve repair or replacement, or an implanted vena cava filter
- •Subject has evidence of tricuspid stenosis, tricuspid atresia, or presence of any condition that precludes appropriate vascular access for the study procedure
- •Subject has previous myocardial infarction
- •Subject is expected to be pacemaker dependent
- •Subject has a previous or existing lead or device in the right heart or interventricular septum (includes lead fragments, temporary pacing leads, and closure devices)
- •Subject has an active implantable electronic device that cannot be turned off during the study procedure
- •Subject has recent cardiovascular or peripheral vascular surgery within 30 days of enrollment
- •Subject has known allergy or hypersensitivity to < 1 mg of dexamethasone sodium phosphate or any blood or tissue contacting material used in the study procedure
- •Subject is unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
- •Subject has known chronic renal insufficiency including patients on dialysis
- •Subject has an active systemic infection
- •Subject has known history or repair of an atrial septal defect, patent foramen ovale, or ventricular septal defect
- •Subject is currently participating in another clinical investigation that might impact the outcomes of the clinical investigation
- •Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
- •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with the follow-up requirements of the clinical investigation
- •Subject is unable to read or write
研究组 & 干预措施
Treatment Arm
干预措施: AVEIR CSP Leadless Pacemaker System (Device)
结局指标
主要结局
Percentage of Participants Free From AVEIR CSP related Complications at 1-month
时间窗: 1 month
AVEIR CSP Leadless Pacemaker (LP) System complication-free-rate. A complication is defined as an AVEIR CSP LP device or AVEIR CSP procedure-related serious adverse event.
Average AVEIR CSP LP Pacing Thresholds and Sense Amplitude Measurements at 1-month
时间窗: 1 month
Pacing Thresholds at 0.4 ms pulse width and sense amplitudes of the AVEIR CSP LP by capture type at 1 month.
次要结局
- Percentage of Participants Free From AVEIR CSP related Complications at 3-months(3 months)
- Average AVEIR CSP LP Pacing Thresholds and Sense Amplitude Measurements at 3 months(3 months)