NL-OMON32443已完成3 期
Echocardiography Guided Cardiac Resynchronization Therapy Clinical Investigation - EchoCRT
BIOTRONIK Inc. - clinical study department0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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
- •indication for ICD
- •systolic heart failure: LVEF < 35% and LVEDD > 55 mm
- •NYHA III-IV under optimal medical therapy
- •QRS < 130 ms
- •ventricular dyssynchrony measured by Echo + confirmed by Echo Core Lab
- •18 years of age or older
排除标准
- •Contraindication(s) to an ICD.
- •Already implanted with a pacemaker or an ICD
- •Bradycardia pacing indication
- •Pregnant, lactating or planning to become pregnant females.
- •CABG, PTCA, or MI within the past 3 months prior to enrollment or CABG or PTCA intervention planned in the next 3 months.
- •Irreversible brain damage from preexisting cerebral disease.
- •Reversible non-ischemic cardiomyopathy such as acute viral myocarditis.
- •Permanent 2º or 3º heart block.
- •Chagas disease.
- •Persistent, permanent, or paroxysmal atrial fibrillation within 1 month prior to enrollment.
- •Expected to receive heart transplantation within 6 months.
- •Have a life expectancy of less than 6 months
- •Creatinine > 2.5 mg/dL or liver failure
研究者
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