jRCT2032220135进行中（未招募）不适用
ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
Medtronic Japan0 个研究点目标入组 15 人开始时间: 2023年2月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 主要终点
- Freedom from major complications
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patient has a Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines, or ESC guidelines.
- •Patient is at least 18 years of age and meets age requirements per local law.
- •Patient 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
- •Patient is unwilling or unable to personally provide Informed Consent.
- •Patient has indications for bradycardia pacing or Cardiac Resynchronization Therapy (CRT) (Class I, IIa, or IIb indication).
- •Patients with an existing pacemaker, ICD, or CRT device implant or leads.
- •Patients with these medical interventions are excluded from participation in the study:
- •Prior sternotomy
- •Any prior medical condition or procedure that leads to adhesions in the anterior mediastinal space (i.e., prior mediastinal instrumentation, mediastinitis)
- •Prior abdominal surgery in the epigastric region
- •Planned sternotomy
- •Prior chest radiotherapy
- •Or any other prior/planned medical intervention not listed that precludes their participation in the opinion of the Investigator.
- •Patient has previous pericarditis that:
- •Was chronic and recurrent, or
- •Resulted in pericardial effusion, or
- •Resulted in pericardial thickening or calcification.
- •Patients with these medical conditions or anatomies are excluded from participation in the study:
- •Hiatal hernia that distorts mediastinal anatomy
- •Marked sternal abnormality (e.g., pectus excavatum)
- •Decompensated heart failure
- •COPD with oxygen dependence
- •Gross hepatosplenomegaly
- •Or any other known medical condition or anatomy type not listed that precludes their participation in the opinion of the Investigator.
- •Patients with a medical condition that precludes them from undergoing defibrillation testing:
- •Severe aortic stenosis
- •Intracardiac LA or LV thro
- •Severe proximal three-vessel or left main coronary artery disease without revascularization
- •Hemodynamic instability
- •Unstable angina
- •Recent stroke or transient ischemic attack (within the last 6 months)
- •Known inadequate external defibrillation
- •LVEF < 20%
- •LVEDD >70 mm
- •Or any other known medical condition not listed that precludes their participation in the opinion of the Investigator.
- •Patient with any evidence of active infection or undergoing treatment for an infection
- •Patient is contraindicated from temporary suspension of oral/systemic anticoagulation
- •Patient with current implantation of neurostimulator or any other chronically implanted device that delivers current in the body.
- •Patient meets ACC/AHA/HRS or ESC clinical guideline Class III criteria for an ICD (e.g., life expectancy of less than 12 month).
- •Patient 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.
- •Patient with any exclusion criteria as required by local law (e.g., age or other).
- •Pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence.
结局指标
主要结局
Freedom from major complications
时间窗: 2 weeks post-implant
Characterize the freedom from major complications related to the EV ICD System and/or procedure
Defibrillation testing success rate
时间窗: at implant
Characterize the EV ICD defibrillation testing success rate
次要结局
- Characterize electrical performance(over time)
- Characterize EV ICD defibrillation testing conducted per physician discretion
- Characterize appropriate and inappropriate shocks
- Characterize extracardiac pacing sensation
- Characterize asystole pacing
- Summarize ATP performance with spontaneous arrhythmias
- Summarize adverse events
研究者
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