DRKS00011133已完成4 期
Impact of right heart function and pulmonary venous Hypertension on CRT Response in patients with left ventricular dysfunction and dyssynchrony - Bivent
niversitätsklinikum Magdeburg0 个研究点目标入组 115 人开始时间: 2017年1月30日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 115
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one(—)
- 性别
- All
入选标准
- •1. Patients with heart failure symptoms lasting at least 6 weeks (according to the
- •current guidelines for CRT treatment of chronic heart failure)
- •2. At least 18 years of age
- •3. Medical need for implants (implants based on the standard implant guidelines
- •from the European Society of Cardiology (ESC))
- •4. Left ventricular ejection fraction (LVEF) < 35% as assessed by the investigator
- •5. NYHA functional status II, III or IV
- •6. QRS duration > 130 ms
- •7. Medical therapy, unless contraindicated, includes
- •- ACE inhibitor or
- •- AT1 blocker given for at least one month before enrolment,
- •- Beta-blocker started at least 3 months before enrolment,
- •- aldosterone antagonist
- •Dosage of therapies mentioned above must be unchanged for at least one month.
- •8. The patient must have given its written informed consent to participate in the
- •study after receiving adequate previous information and prior to any study
- •specific procedures.
排除标准
- •1. Life expectancy < 12 months
- •2. Pregnancy (routine test before left and right heart catheter examination)
- •3. Prior CRT
- •4. Atrial arrhythmias
- •5. Right bundle branch block
- •6. QRS < 130 ms
- •7. Heart failure requiring continuous intravenous therapy
- •8. Patients with acute coronary syndromes or coronary revascularization within 4
- •months before CRT
研究者
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