Subcostal Temporary Extravascular Pacing V (STEP V) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Freedom from ADEs
研究概览
简要总结
The STEP V Study is a prospective, multicenter, acute (in-hospital), single-arm feasibility study. The objective of the study is to evaluate the early safety and performance of the latest AtaCor EV Temporary Pacing Lead System over a two-day use period.
详细描述
The primary safety objective is freedom from Adverse Device Effects (ADE). The primary performance objective is summary statistics for pacing capture threshold, impedance, and sensed R-wave amplitude with the StealthTrac Lead from insertion through removal.
Up to three (3) Investigational Sites will participate with up to 50 subjects enrolled in the study. Subjects indicated for closed-chest cardiac invasive procedures will be eligible for participation. Subjects undergoing a qualifying index procedure will have a Model AC-101400 StealthTrac Lead inserted and evaluated over the follow-up period. Subject participation is expected to be 2 days with the Study Lead inserted, plus 30 days post lead removal. A 30 day (+/-3 days) post-removal follow-up will also be performed to document any latent adverse events. Subjects remain enrolled until completion of the 30-Day Follow Up.
The maximum duration for study participation is 33 days. Study duration estimated to be 3 years after the first study enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •At least 18 years old
- •Subjects indicated for closed-chest cardiac invasive procedure, including:
- •Transarterial transcatheter aortic valve implantation (TAVI)
- •Transarterial balloon aortic valvuloplasty (BAV)
- •Cardiovascular implantable electronic device (CIED) pulse generator replacement
- •Cardiovascular implantable electronic device (CIED) lead extraction or revision
排除标准
- •BMI ≥ 35 kg/m2
- •Septic shock
- •Severe anemia
- •Patients on dual antiplatelet therapy or anti-coagulation that cannot be stopped for the procedure
- •Circumstances that prevent data collection or follow-up (e.g., inability to perform a short walk with the Holter monitor)
- •Participation in any concurrent clinical study without prior written approval from the Sponsor
- •Inability or unwillingness to provide informed consent to participate in the Study
- •Known prior history for any of the following:
- •Median or partial sternotomy
- •Acute coronary syndrome within past 90 days
- •NYHA Functional Classification IV within past 90 days
- •Surgically corrected congenital heart disease (not including catheter-based procedures)
- •Allergies to the device materials such as stainless steel, titanium, platinum, iridium, polyethylene, polyurethane, polycarbonate and silicone
- •Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium, including adhesions
- •Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
- •Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments which may complicate the AtaCor EV Temporary Pacing Lead System insertion procedure
- •Any conditions which may complicate the AtaCor EV Temporary Pacing Lead System insertion procedure
- •Pericardial disease, pericarditis and mediastinitis
- •Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions
- •FEV1 < 1 liter
研究组 & 干预措施
AtaCor EV Temporary Pacing Lead System
Subjects implanted with the AtaCor StealthTrac Lead Model AC-101400
干预措施: AtaCor StealthTrac Lead (Device)
结局指标
主要结局
Freedom from ADEs
时间窗: Up to 2 days post-insertion
Freedom from Adverse Device Effects (ADE)
Sensed R-Wave Amplitude (mV)
时间窗: Up to 2 days post-insertion
Summary statistics for sensed R-wave amplitude with the StealthTrac Lead from insertion through removal
Pacing Capture Threshold (mA or V)
时间窗: Up to 2 days post-insertion
Summary statistics for pacing capture threshold with the StealthTrac Lead from insertion through removal
Impedance (Ohms)
时间窗: Up to 2 days post-insertion
Summary statistics for impedance with the StealthTrac Lead from insertion through removal
次要结局
未报告次要终点