ACC - Atrial Contribution to CRT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Optimal AV-Delay (AVD)
研究概览
简要总结
This prospective study will evaluate in patients, fulfilling implant criteria for Cardiac Resynchronisation Therapy (CRT) implant, the optimal atrial contribution to the resynchronised ventricles in the event of right atrial pacing.
详细描述
All patients will undergo advanced echocardiographic examination pre-operative, pre-discharge after implantation and at 3 and 6-months follow-up. AV-delay optimization will be performed using aortic VTI measured by continuous wave Doppler in a modified 4-chamber view. During optimisation aortic VTI will be measured at different heart rates reached by increasing atrial pacing 10, 20 and 30 beats above intrinsic heart rate (IHR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms of heart failure
- •Left ventricular dysfunction
- •Ventricular dyssynchrony
- •18 years or of legal age in order to give informed consent according to national laws
- •Able to understand the nature of the procedure
- •Available for follow-up on a regular basis at an approved investigational center
排除标准
- •Atrial Fibrillation
- •Life expectancy of less than six months due to other medical conditions
- •For women: pregnancy or absence of medically accepted birth control
- •Inability or refusal to sign the Patient Informed Consent
- •Inability or refusal to comply with the follow up schedule or protocol requirements
- •Inability to undergo device implant, including general anaesthesia if required
- •Mechanical tricuspid prosthesis
- •Currently enrolled in another investigational study, including drug investigations
- •Hypertrophic Obstructive Cardiomyopathy (HOCM)
- •Not meeting the inclusion criteria
结局指标
主要结局
Optimal AV-Delay (AVD)
时间窗: Implant (baseline), 3 months and 6 months Follow-up
Optimal AV-Delay will be measured at implant (baseline ), 3months and 6 months Follow-up for intrinsic heart rate, and 10, 20 and 30 Bpm above intrinsic heart rate.
Aortic Velocity Time Integral (VTI)
时间窗: At implant (baseline), 3 months and 6 months Follow-up
Velocity time integral of the aortic flow correlates with cardiac output and is an accepted parameter for optimization of Cardiac Resynchronization Therapy (CRT).
次要结局
- 6 Minute Walk Test(implant (baseline), 3 months and 6 months Follow-up)
- Left Ventricular Ejection Fraction (LVEF)(implant (baseline), 3 Months, 6 Months)