NL-OMON43344已完成4 期
A prospective, multi-center, post market randomized controlled trial comparing VT ablation outcomes using remote MAGNETIC navigation guided substrate mapping and ablation versus manual approach in a low LVEF population - The MAGNETIC-VT Study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Stereotaxis
- 入组人数
- 80
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
- 18 至 99（—）
入选标准
- •1. Patient is 18 years of age or older;
- •2. Patient has provided written informed consent;
- •3. Patient has an implantable cardioverter defibrillator (ICD) previously implanted;
- •4. Drug refractory monomorphic VT;
- •5. Patient is a candidate for ischemic VT RF ablation;
- •6. Patient has had a myocardial infarction;
- •7. LVEF * 35%.
排除标准
- •1. Non-ischemic VT;
- •2. History of stroke within 1 month prior to enrollment;
- •3. Acute MI within 30 days prior to enrollment;
- •4. Unstable angina;
- •5. Cardiac surgery within 60 days prior to enrollment;
- •6. Patient is pregnant or nursing;
- •7. Limited life expectancy of 1 year or less (Subjects requiring LVAD/IABP intraprocedural support may be enrolled as long as life expectancy is at least 1 year following the ablation procedure.)
- •8. Patient is unable or unwilling to cooperate with the study procedures;
- •9.. Known presence of intracardiac thrombi determined by echocardiography;
- •10. Major contraindication to anticoagulation therapy or coagulation disorder;
- •11. Previous pericarditis or cardiac tumor;
- •12. Previous thoracic radiation therapy;
- •13. Any other reason the investigator considers the subject ineligible.
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