NL-OMON35451已完成不适用
Optimization of Cardiac Resynchronization Therapy at rest and during exercise conditions. - OPTI-CARE
niversitair Medisch Centrum Utrecht0 个研究点目标入组 51 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
- 已完成
- 发起方
- 入组人数
- 51
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Indication for Cardiac Resynchronization Therapy according to the current international guidelines. (See research protocol: chapter 5.2)
排除标准
- •Criteria for the complete study: (see also research protocol chapter 5.3)
- •-Contraindications for implantation of a CRT device;
- •-Age <18 years or incapacitated adult;
- •-Participation in another clinical study that prohibits any procedures other than standard;
- •-Pregnancy;
- •-Severe aortic stenosis with a valve area <1,0 cm2 or aortic valve replacement in history.;Specific criteria for the infusion of dobutamine (see research protocol chapter 5.3 and 6.2.1):
- •-Significant abnormalities on coronary angiogram or myocardial perfusion scan (part of standard procedure before CRT implantation) that are not treated by coronary artery bypass graft or percutaneous coronary intervention;
- •-Atrial fibrillation with a fast ventricular response (heart rate >100 bpm);
- •-Baseline heart rate <10 beats per minute below target heart rate;
- •-Sinus bradycardia <40 beats per minute at baseline;
- •-Open operation wound for more than 3 hours before start of dobutamine infusion (only applies to dobutamine infusion during device implantation);
- •-Contraindications for dobutamine (baseline systolic blood pressure >180 mmHg or <80 mmHg, hemodynamic significant left ventricular outflow tract obstruction, aortic aneurysm, aortic dissection);
- •-Insufficient image quality during echocardiography at rest (only applies to dobutamine stress echocardiography);
- •-Experienced secondary endpoint (side effect) during dobutamine stress echocardiography (only applies to dobutamine infusion during device implantation).
研究者
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