CTRI/2025/07/090144已完成3 期
A Stylet-Driven ICD Lead Intended for Conduction System Pacing IDE Study
Abbott India Pvt. Ltd.3 个研究点 分布在 1 个国家目标入组 414 人开始时间: 2025年7月21日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 414
- 试验地点
- 3
- 主要终点
- - The primary safety endpoint evaluates the 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, based on Clinical Event Committee (CEC) adjudication of adverse events.
研究概览
简要总结
This clinical study will evaluate the safety and effectiveness of the CSP ICD Lead when implanted at the LBBA location in a subject population indicated for ICD or CRT-D therapy.
It is a Prospective, global, single-arm, multi-center IDE study.
The study will enroll up to 414 subjects at up to 70 sites worldwide (US, Canada, EMEA, and APAC) to analyze the primary endpoints.
The subjects will be followed at baseline, implant procedure, pre (hospital) discharge, and follow-up at 3 months (primary endpoints evaluation), 6 months, and every 6 months thereafter until study completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
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: a.
- •de novo Abbott ICD system implant (single or dual chamber) b.
- •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 more than 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
- •General Exclusion Criteria
- •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 less than or equal to 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 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 any other known medical condition not listed that precludes their participation in the opinion of the investigator.
结局指标
主要结局
- The primary safety endpoint evaluates the 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, based on Clinical Event Committee (CEC) adjudication of adverse events.
时间窗: 3 months post-implant
次要结局
- To evaluate the 3-month composite success rate of acceptable pacing capture thresholds & R-wave sense amplitudes of the CSP ICD Leads in the subjects with the CSP ICD Lead implanted at the LBBA. Acceptable ranges for pacing capture threshold & sense amplitude are shown below:(- Pacing threshold less than or equal to 2.5V at pulse width of 0.5ms)
- To evaluate the 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.(Implant)
研究者
Dr Sumit Anand
Abbott India Pvt.Ltd.
研究点 (3)
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