Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 998
- 试验地点
- 110
- 主要终点
- LEADR: Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead
研究概览
简要总结
The LEADR study is designed to assess the safety and efficacy of the Next Generation ICD lead.
The LEADR LBBAP study is being conducted under the existing US FDA Investigational Device Exemption (IDE) for the Next Generation ICD Lead and is designed to confirm the safety and defibrillation efficacy of the Next Generation ICD Lead when placed in the LBBAP location in ICD and LOT-CRT patient population.
详细描述
The LEADR and LEADR LBBAP studies will enroll subjects who are indicated to receive an implantable single or dual chamber ICD, or CRT-D, and who meet all of the inclusion criteria and none of the exclusion criteria. Subjects will receive an investigational Next Generation ICD Lead. Subjects in the LEADR study will be followed for at least 18 months following Next Generation ICD Lead implantation in a septal (non-LBBAP) or apical implant location. Enrollment in the LEADR study has been completed (675 subjects enrolled). Subjects in the LEADR LBBAP study will be followed for at least 3 months (ICD-indicated subjects) or 6 months (CRT-indicated subjects) following Next Generation ICD Lead implantation in an LBBAP implant location. Enrollment in the LEADR LBBAP study has been completed (323 subjects enrolled).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LEADR Inclusion Criteria:
- •Subject meets current clinical practice guidelines for implantation of ICD or CRT-D and will undergo one of the following:
- •de novo Medtronic CRT-D system implant
- •de novo Medtronic ICD system implant (single or dual chamber)
- •Subject has, per local law and requirements, the minimum age for autonomously signing an ICF (minimum age of 18 years)
- •Subject is willing to undergo implant defibrillation testing if requested.
- •Subject is geographically stable and willing and able to complete the study procedures and visits for the duration of the follow-up.
排除标准
- •Subject is unwilling or unable to personally provide Informed Consent.
- •Subject has contraindications for standard RV transvenous lead placement (e.g., mechanical right heart valve).
- •Subject is contraindicated for ≤1 mg dexamethasone acetate.
- •Subject has a life expectancy of less than 12 months
- •For subject undergoing defibrillation testing the following medical conditions exclude them:
- •Pre-existing or suspected pneumothorax during implant
- •Current intracardiac left atrial or left ventricular (LV) thrombus
- •Severe aortic stenosis
- •Severe proximal three-vessel or left main coronary artery disease without revascularization
- •Unstable angina
- •Ejection Fraction less than 25%
- •Recent stroke or transient ischemic attack (within the last 6 months)
- •Known inadequate external defibrillation
- •Any other known medical condition not listed that precludes their participation in the opinion of the investigator
- •Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager.
- •Subject with any exclusion criteria as required by local law (e.g., age or other).
- •Pregnant women or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence
- •Subject with an existing pacemaker (including transcatheter pacing system), ICD, or CRT device or leads
- •Subject with any evidence of active infection or undergoing treatment for an infection
- •Recent (or planned) cardiac surgery or stenting less than 1 month before implant
- •End stage renal disease
- •Subjects with NYHA IV classification
- •Subjects with a transplanted heart
- •Subjects with previously extracted leads
- •Subjects with Left Ventricular Assist Device
- •LEADR LBBAP Inclusion Criteria:
- •Subject meets current local clinical practice guidelines for implantation of ICD (single or dual chamber) or CRT-D system and will undergo one of the following:
- •a) De novo Medtronic ICD system implant (single or dual chamber) or b) De novo Medtronic CRT-D system implant and is intended to also undergo LV lead implant (for patients indicated for CRT-D according to locally approved indications/indications)
- •Subject is 12 years of age or older and also is greater than 30 kg in weight at time of enrollment, has cardiac anatomy conducive to RV coil placement, and is allowed to participate in study per local law and requirements. Subjects from 12 years of age until adult also have a separate indication for pacing or CRT or are anticipated to develop one.
- •Subject provides written authorization and/or consent per institution and geographical requirements.
- •Subject is geographically stable and willing and able to complete the study procedures and visits for the duration of the follow-up
- •Subject is willing to undergo implant defibrillation testing if requested
- •LEADR LBBAP Exclusion Criteria:
- •Subject has contraindication for screw-in active fixation transvenous lead placement (e.g., mechanical right heart valve)
- •Subject is contraindicated for ≤1 mg dexamethasone acetate
- •Subject has a life expectancy of less than 12 months
- •For subject undergoing defibrillation testing the following medical conditions exclude them:
- •Pre-existing or suspected pneumothorax
- •Current intracardiac left atrial or LV thrombus
- •Severe aortic stenosis
- •Severe proximal three-vessel or left main coronary artery disease without revascularization
- •Unstable angina
- •Recent stroke or transient ischemic attack (within the last 6 months)
- •Known inadequate external defibrillation
- •Any other known medical condition not listed that precludes their participation in the opinion of the investigator
- •Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
- •Subject is pregnant or breastfeeding, or subject is of childbearing potential and not on a reliable form of birth regulation method or abstinence
- •Subject with an existing pacemaker (including transvenous and transcatheter pacing system), ICD (transvenous) or CRT-D (transvenous) device or leads
- •Subject with previous subcutaneous ICD (S-ICD), extravascular ICD (EV ICD) or Implantable Cardiac Monitor explanted within 30 days before implant
- •Subject with any evidence of active bacterial infection or undergoing treatment for a bacterial infection within the last 30 days
- 另有 7 项未显示
结局指标
主要结局
LEADR: Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead
时间窗: Day 1
Defibrillation testing will be completed in a subset of subjects at implant.
LEADR: Estimate the rate of major Lead complication-free rate at 6 months
时间窗: Implant to 6 Months
Subjects free of Next Generation ICD lead-related complication at 6 months post-implant.
LEADR LBBAP: The lead-related major complication rate at 3-months
时间窗: Implant to 3 Months
Subjects free of Next Generation ICD lead-related complication at 3 months post-implant.
LEADR LBBAP: Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead
时间窗: Day 1
Defibrillation testing will be completed with the Next Generation ICD Lead in the LBBAP location in a subset of subjects at implant.
次要结局
- LEADR: Estimate the fracture-free rate of the Next Generation ICD lead(up to 24 months)