JPRN-jRCT2072210078招募中3 期
ead EvaluAtion for Defibrillation and Reliability - LEADR
Yamamoto Takuto0 个研究点目标入组 25 人开始时间: 2021年10月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Subject meets current clinical practice guidelines for ICD or CRT-D implantation and will undergo one of the following:
- •- de novo Medtronic CRT-D system implant
- •- de novo Medtronic ICD system implant (single or dual chamber)
- •2.Subject has, per local law and requirements, the minimum age for autonomously signing an ICF
- •3.Subject is willing to undergo implant defibrillation testing if requested.
- •4.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
- •1.Subject is unwilling or unable to personally provide Informed Consent.
- •2.Subject has contraindications for standard RV transvenous lead placement (e.g., mechanical right heart valve).
- •3.Subject is contraindicated for <= 1 mg dexamethasone acetate.
- •4.Subject has a life expectancy of less than 12 months
- •5.Subject is unable to undergo defibrillation testing due to physician judgement or medical conditions such as
- •- 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
- •6.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.
- •7.Subject with any exclusion criteria as required by local law (e.g., age or other).
- •8.Pregnant women or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence
- •9.Subject with an existing pacemaker (including transcatheter pacing system), ICD, or CRT device or leads
- •10.Subject with any evidence of active infection or undergoing treatment for an infection
- •11.Recent (or planned) cardiac surgery or stenting less than 1 month before implant
- •12.End stage renal disease
- •13.Subjects with NYHA IV classification
- •14.Subjects with a transplanted heart
- •15.Subjects with a history of extracted leads
- •16.16. Subjects with Left Ventricular Assist Device
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