JPRN-UMIN000039469
招募中
3 期
ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study - ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Medtronic Japan Co., Ltd.
- 入组人数
- 15
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- 未提供
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 or leads. 4\. Patients with these medical interventions are excluded from participation in the study: 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: 6\. Patients with these medical conditions or anatomies are excluded from participation in the study: 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: 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.
结局指标
主要结局
未指定
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