JPRN-jRCT2032220135进行中（未招募）3 期
ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
Yamamoto Takuto0 个研究点目标入组 15 人开始时间: 2022年6月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Patient has a Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines, or ESC guidelines.
- •2.Patient is at least 18 years of age and meets age requirements per local law.
- •3.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
- •1.Patient is unwilling or unable to personally provide Informed Consent.
- •2.Patient has indications for bradycardia pacing or Cardiac Resynchronization Therapy (CRT) (Class I, IIa, or IIb indication).
- •3.Patients with an existing pacemaker, ICD, or CRT device implant or leads.
- •4.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.
- •5.Patient has previous pericarditis that:
- •-Was chronic and recurrent, or
- •-Resulted in pericardial effusion, or
- •-Resulted in pericardial thickening or calcification.
- •6.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.
- •7.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.
- •8.Patient with any evidence of active infection or undergoing treatment for an infection
- •9.Patient is contraindicated from temporary suspension of oral/systemic anticoagulation
- •10.Patient with current implantation of neurostimulator or any other chronically implanted device that delivers current in the body.
- •11.Patient meets ACC/AHA/HRS or ESC clinical guideline Class III criteria for an ICD (e.g., life expectancy of less than 12 month).
- •12.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.
- •13.Patient with any exclusion criteria as required by local law (e.g., age or other).
- •14.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.
研究者
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