A Stylet-Driven ICD Lead Intended for Conduction System Pacing IDE Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 414
- 试验地点
- 62
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
This is a prospective, multi-center, global, single-arm, pivotal investigational study designed to evaluate the safety and effectiveness of the CSP ICD Lead in a subject population indicated for ICD or CRT-D therapy.
The clinical investigation will enroll up to 414 subjects at up to 70 participating centers from the United States, Canada, Europe, and Asia Pacific.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must meet current clinical practice guidelines for implantation of ICD or CRT-D and will undergo one of the following:
- •de novo Abbott ICD system implant (single or dual chamber)
- •de novo Abbott CRT-D system implant and is intended to also undergo left ventricle coronary sinus lead implant (for patients indicated for CRT-D according to locally approved indications)
- •Subject is ≥ 18 years of age or age of legal consent, whichever age is greater.
- •Subject is willing to undergo implant defibrillation testing if requested. Subjects with AF in whom defibrillation testing is required must have been on or willing to be on uninterrupted anticoagulation therapy before, during, and after the implant procedure.
- •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 has had myocardial infarction or unstable angina within 40 days prior to signing consent
- •Subject has had recent cardiac revascularization (angioplasty, stent or bypass graft) in the 4 weeks prior to signing consent or planned within 3 months following consent
- •Subject has had any other therapeutic cardiovascular procedure (such as transcatheter aortic valve replacement, MitraClip, cardiac surgery, left atrial appendage closure, patent foramen ovale closure, or any ablation procedures) in the 3 months prior to signing consent or planned within 3 months following consent
- •Subject has had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months of prior to signing consent
- •Subject has a life expectancy of less than 12 months
- •Subject has contraindications for standard RV transvenous and/or LBBAP lead placement (e.g., mechanical right heart valve)
- •Subject is contraindicated for ≤1mg Dexamethasone sodium phosphate.
- •Subject is pregnant or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence
- •Subject has an existing pacemaker (including a temporary pacing system), ICD, CRT, or cardiac contractility modulation (CCM) device or leads
- •Subject has any evidence of active infection or undergoing treatment for an infection
- •Subject is enrolled or planning to enroll in another clinical trial that might confound the results of the present study
- •Subject has moderate or severe aortic stenosis
- •Subject has ventricular septal defect (VSD) or had prior surgery on the interventricular septum that could impact LBBAP implant, such as septal myomectomy, ethanol septal ablation, VSD repair, etc
- •Subject has end-stage renal disease
- •Subject has NYHA IV classification
- •Subject has undergone cardiac transplantation or have a classification of Status 1 for cardiac transplantation or consideration for transplantation during the study follow-up period
- •Subject has had previously extracted leads
- •Subject has had an LV Assist Device
- •Subject has had a failed LBBAP lead implant
- •Defibrillation testing exclusion criteria (these are part of general exclusion criteria when defibrillation testing is requested):
- •Subject has pre-existing or suspected pneumothorax during implant
- •Subject has current known intracardiac left atrial or Left Ventricular thrombus
- •Subject has severe proximal three-vessel or left main coronary artery disease without revascularization
- •Subject has Ejection Fraction less than 20%
- •Subject has recent stroke or transient ischemic attack (within the last 6 months)
- •Subject has known inadequate external defibrillation
- •Subject has any other known medical condition not listed that precludes their participation in the opinion of the investigator
研究组 & 干预措施
Treatment
Subjects undergoing ICD/CRT implant will be implanted with the CSP ICD Lead in the LBBAP location and undergo required electrical testing
干预措施: LBBAP Implant with a CSP ICD Lead (Device)
结局指标
主要结局
Primary Safety Endpoint
时间窗: 3 months post-implant
Freedom from CSP ICD Lead-related Serious Adverse Device Effects (SADEs) through 3 months post-implant for subjects in which the CSP ICD Lead implant was attempted
Primary Effectiveness Endpoint 1
时间窗: 3-months post-implant
3-month composite success rate of acceptable pacing capture thresholds and R-wave sense amplitudes of the CSP ICD Leads in the subjects with the CSP ICD Lead implanted at the LBBA
Primary Effectiveness Endpoint 2
时间窗: at implant
Success rate of the defibrillation testing at implant in the subjects who complete the defibrillation test with the CSP ICD Lead implanted at the LBBA
次要结局
未报告次要终点