Individually Tailored Cardiac Resynchronization Therapy - Combing Myocardial Strain and Cardiac CT to Optimize Left Ventricular Lead Placement in Cardiac Resynchronization Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Positive response to CRT treatment
研究概览
简要总结
For patients with advanced heart failure, Cardiac Resynchronization Therapy (CRT) has been a major improvement. The treatment improves symptoms and prolongs life in selected patients with heart failure. However, with the current selection criteria and methods for implanting the pacemaker, only 60-70% of the patients derive significant benefit from the treatment.
New imaging techniques, including advanced ultrasound and computed tomography, in combination with new versatile multi-pole electrodes, have made an individually tailored therapy possible. Using these techniques in combination, the study will investigate the effect of individually based "optimal" placement of the pacemaker electrodes vs. standard care. The optimal LV electrode position is defined as pacing a viable segment with the latest mechanical delay, targeting a specific segment of the coronary sinus as visualised on cardiac CT. The hypothesis is that this will increase the number of positive responders from 65% to 85%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Symptomatic heart failure (New York Heart Association functional class II - IV) despite stabile optimal medical therapy.
- •Wide QRS ≥ 120 milliseconds on standard ECG.
- •LV systolic dysfunction (EF ≤ 35%).
- •Written informed consent.
- •Accepted for CRT-P or CRT-D treatment
排除标准
- •Life expectancy < 12 months.
- •Recent myocardial infarction (< 3 months).
- •Significant valve disease
- •Chronic atrial fibrillation
- •Pregnancy
- •Severely impaired renal function (estimated glomerular filtration rate (eGFR) < 30 ml/min)
- •Unable to give written informed consent.
研究组 & 干预措施
Imaging guided LV lead positioning
干预措施: Imaging guided LV lead positioning (Other)
Standard LV lead positioning
The LV lead position is decided at the discretion of the treating physician. Cardiac CT images are available for viewing, but no echocardiography data regarding segmental myocardial strain are available.
结局指标
主要结局
Positive response to CRT treatment
时间窗: 6 months
The primary efficacy endpoint will evaluate the effect of echocardiography and cardiac CT guided placement of the left ventricular lead vs standard care (i.e. position of the left ventricular lead at the discretion of the treating physician). Number of patients with positive response to CRT (YES or NO). A positive response is defined as survival in combination with either a reduction in end systolic left ventricular volume ≥ 15% by echocardiography ("volume responder") and / or improvement ≥ 1 NYHA class and ≥10% improvement in 6 minute hall walk test ("clinical responder").
次要结局
- Quality of life(6 months 2 years 5 years)
- Ventricular tachycardia(6 months 2 years and 5 years)
- Heart failure morbidity(6 months 2 years and 5 years)
- Myocardial viability(6 months)
- Biochemical markers of heart failure(6 months)
- Left ventricular systolic function(6 months)
- Response to CRT (on-treatment analysis)(6 months)
- Mortality(6 months, 2 years and 5 years)
- Left ventricular dyssynchrony(6 months)
- Left ventricular diastolic dimension(6 months)
- Morbidity and mortality(6 months 2 years and 5 years)
- MRI left ventricular dyssynchrony(6 months)
- Myocardial viability(Peroperative)