NL-OMON29327招募中不适用
Advanced Image Supported Lead Placement in Cardiac Resynchronization Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
研究概览
简要总结
For previous work, please see Salden OAE et al. Multimodality imaging for real-time image-guided left ventricular lead placement during cardiac resynchronization therapy implantations. 2019. Int J Cardiovasc Imaging. 2019 Jul;35(7):1327-1337.
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Heart failure with LV ejection fraction = 35%;
- •- New York Heart Association class II, III, or IV (ambulatory);
- •- Optimal medical treatment that is tolerable;
- •- Left bundle branch block (LBBB) and QRS = 130 ms, OR non-LBBB and QRS = 150 ms.
排除标准
- •Contraindications for implantation of a CRT device;
- •- Age <18 years or incapacitated adult;
- •- Pregnancy or 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 an MRI scan
- •- Participation in another clinical study that prohibits any procedures other than standard.
研究者
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