Subanalysis in Patients With CARDIoLAMinopathy Enrolled to Retrospective and Observational Registy on Cardiac Contractility Modulation 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 of QoL
研究概览
简要总结
Observational, retrospective registry with acute and chronic endpoints
详细描述
This registry includes patients who have undergone CCM device implant and due to the presence of heart failure with reduced left ventricular systolic function and symptomatic despite optimal therapy, with LMNA-DCM etiology for to assess the impact on CCM therapy in term of improvemente of QoL and reduction HF hospitalizations
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 —（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 of QoL
时间窗: 12 months
Evaluation of the effect of CCM therapy on Quality of Life evaluated from the reduction of MLWHFQ score 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 collected during the FU post implant of CCM device compared to number of Hospitalizations and Emergenncy Ward accesses collected 1 year before the implant of CCM therapy device
Improvement of Fuctional Capacity
时间窗: 12 months
Evaluation of the impact of CCM therapy on Functional Capacity evaluated from the gain of the distance travelled in the 6MWT at FU post implant of CCM therapy device compared to baseline
次要结局
- Assess of HF biomarkers trends(12 months)
研究者
Antonio D'Onofrio
Head of UOSD Elettrofisiologia Studio e Terapia delle Aritmie
Monaldi Hospital