Observational and Prospective Registry on Cardiac Contractility Modulation (CCM) Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Improvement Quality of Life
研究概览
简要总结
Observational and perspective study with acute and chronic endpoint.
详细描述
This registry includes patients who have undergone implantation of the cardiac contractility modulation device due to the presence of heart failure with reduced left ventricular systolic function and symptomatic despite optimal therapy, as indicated in the guidelines of the ESC of 2016 and the Expert Consensus Document of the ESC Heart Failure group published in May 2019 for to assess the benefits after the CCM device.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-pregnant female, aged 18 or older;
- •chronic heart failure with symptomatic left ventricular systolic function; (NYHA class II-IVa) with or without device already implanted (for example AICD, pace-maker);
- •Appropriate and optimized medical therapy
- •Patient signed and dated informed consent form at enrollment;
- •life expectancy> 1 year due to the absence of comorbidities that reduce the prognosis
排除标准
- •absence of venous access available for implant;
- •contraindication to the interventional procedure of CCM device implant (for example presence of Mechanical tricuspid vale);
- •pregnant patients
结局指标
主要结局
Improvement Quality of Life
时间窗: 12 months
Evaluatation of the impact on CCM Therapy on Quality of Life evaluated from the reduction of MLWHFQ score at FU post implant of CCM device compared to baseline
Functional Capacity
时间窗: 12 months
Evaluation of the impact on CCM Therapy on Functional Capacity evaluated from the gain of distance traveled in the 6MWT at FU post implant of CCM device compared to baseline
Reduction of HF Hospitalizations and Emergency Ward accesses
时间窗: 12 months
Reduction of HF Hospitalizations and Emergency Ward accesses at FU post implant of CCM device compared to number of HF hospitalization an Emergency Ward accesses collected 1 year before the implant of CCM therapy
次要结局
未报告次要终点
研究者
Antonio D'Onofrio
Head of UOSD Elettrofisiologia Studio e Terapia delle Aritmie
Monaldi Hospital