Sensing and Defibrillation With a Commercially Available ICD Coupled With a Parasternal Extravascular Lead (SECURE EV) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Incidence of ADEs
研究概览
简要总结
The SECURE EV Study is a prospective, multi-center, single-arm study without concurrent or historical controls. The objectives of the study are 1) to characterize safety of the AtaCor EV-ICD Lead up to 90 days post-implant, and 2) to characterize sensing and conversion of induced VF up to 90 days post-implant.
详细描述
The primary safety objective of the study is to characterize safety of the AtaCor EV-ICD Lead up to 90 days post-implant. The primary performance objective is to characterize sensing and conversion of induced VF up to 90 days post-implant.
Up to 3 Investigational Sites Worldwide will participate with up to 20 subjects enrolled in the study. Patients undergoing de novo or replacement ICD procedure will be eligible for participation. Study participation requires sub-chronic evaluation of the lead up to 90 days.
Subjects will receive a concomitant EV-ICD System, comprising the investigational EV-ICD Lead connected to a commercially available ICD. Prior to discharge, the EV-ICD will be programmed to monitor only to detect and store ventricular arrhythmias over the 90-day follow-up period.
After the EV-ICD System is removed (up to 90 days post-implant), the Subject will be followed for an additional 30 days then exit the study. The duration of study participation for an individual Subject is 120 ± 7 days. The study is expected to complete within 6 months of the first 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
- Device Feasibility
- 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
- •Indicated for de novo or replacement ICD procedure
排除标准
- •NYHA IV functional class
- •BMI ≥ 35 kg/m2
- •Inotropic therapy in past 180 days
- •Subjects who require continual ventricular pacing
- •Presence or planned use of a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads within the study period.
- •Planned MRI within the study period
- •Subjects on anticoagulation or antiplatelet therapy that cannot be temporarily discontinued for the procedure
- •Logistical or safety related circumstances that may prevent data collection or follow-up
- •Participation in any concurrent clinical study without prior written approval from the Sponsor
- •Inability to give an informed consent to participate in the Study
- •Known prior history for any of the following:
- •Structural abnormalities of the heart that may increase risk of the study procedure or an obstructed/restricted pathway into the mediastinum for the EV-ICD Dilator, EV-ICD Delivery Tool and EV-ICD Lead
- •Uncontrolled paroxysmal, persistent or permanent atrial fibrillation
- •Median or partial sternotomy
- •Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium
- •Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
- •Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the EV-ICD Lead insertion procedure
- •Pericardial disease, pericarditis and mediastinitis
- •Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions
- •FEV1 < 1.0 Liter
- •Surgically corrected congenital heart disease (not including catheter-based procedures)
- •Allergies to the device materials as listed in the Instructions for Use (IFU)
结局指标
主要结局
Incidence of ADEs
时间窗: Up to 120 days post-implant
Incidence of Adverse Device Effects (ADEs)
Induced VF Conversion Success
时间窗: Up to 90 days post-implant
Induced VF conversion success with ≥10 J safety margin 60-90 days post-implant
次要结局
- Detection Time and Time-to-Therapy(Up to 90 days post-implant)
- Induced VF Conversion Success - 30 Days(Up to 30 days post-implant)
- Sensing and Detection of Ventricular Arrhythmias(Up to 90 days post-implant)
- Brady Pacing Electrical Performance: Pacing Impedance(Up to 90 days post-implant)
- Detection Time for VT/VF(Up to 90 days post-implant)
- Brady Pacing Electrical Performance: R-wave Amplitude(Up to 90 days post-implant)
- Lowest Defibrillation Conversion Energy(Procedure)
- Induced VF Conversion Success - Implant(Procedure)
- Brady Pacing Electrical Performance: Pacing Capture Threshold(Up to 90 days post-implant)