NL-OMON54061招募中不适用
Advanced Image Supported Left Ventricular Lead Placement in Cardiac Resynchronization Therapy III - ADVISE-III
niversitair Medisch Centrum Utrecht0 个研究点目标入组 130 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
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
- •An indication for cardiac resynchronization therapy according to the current
- •international evidence based guidelines for CRT (the 2016 European Society of
- •Cardiology Guidelines for Acute and Chronic Heart Failure:
- •- Chronic heart failure;
- •- New York Heart Association functional class II, III, IV (ambulatory);
- •- QRS duration >=130ms;
- •- Optimal pharmacological therapy;
- •- Left ventricular ejection fraction <=35%;
- •- Either a QRS duration >=130ms with left-bundle branch block OR a QRS duration
- •>=150ms without left-bundle branch block.
排除标准
- •Contraindications for implantation of a CRT device;
- •- Age <18 years or incapacitated adult;
- •- Pregnancy; if there is anamnestic doubt regarding postmenopausal state (<1
- •year since last menstruation), a urine hCG test (Alere) will be performed.
- •- Lactation;
- •- Subjects with impaired renal function (severe renal insufficiency, GFR < 30
- •ml/min/1.73m2);
- •- Atrial fibrillation or atrial fibrillation during MRI
- •- Documented allergic reaction to gadolinium;
- •- Impossibility to undergo a MRI scan (determined by using the standard
- •contraindications for MR imaging as used for clinical purposes).
- •- Participation in another clinical study that prohibits or influences any
- •procedures other than standard.
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