Exploring Asynchronism in Operated Fallot Tetralogy : A Comparative Study of Electrical and Mechanical Activation of the Right Ventricle by Three-Dimensional Analysis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Comparison of electrical and mechanical activation by computational morphometry with temporal recalling to define electromechanical activation maps in healthy subjects and patients with Fallot tetralogy operated.
研究概览
简要总结
The objective of this work is to estimate the correlation between the electrical activation of the VD measured by the CARTO electrophysiological mapping system and the mechanical activation of the VD measured by 3D echocardiography and 3D speckle-tracking. Our hypothesis is that there is a strong correlation between electrical activation and mechanical activation in patients with an operated Fallot tetralogy.
详细描述
Fallot tetralogy is the most common cyanogenic congenital heart disease. Thanks to advances in surgery, most patients survive to adulthood but develop a failure of the function of the right ventricle and then of the left ventricle resulting in progressive heart failure and death of patients. Despite corrective surgeries in adulthood, including pulmonary valve surgery, heart failure remains a major problem. One of the mechanisms of this heart failure is the right intraventtricular asynchronism associated with the postoperative right branch block, which will secondaryly become complicated from an interventricular asynchronism for left intraventtricular, partly explaining the overall progressive failure of cardiac function. To date, there is no model for combining a combined analysis of electrical and mechanical activation in the same patients. Understanding these mechanisms would allow us to better understand the pathophysiology of heart failure in this population and to propose targeted therapies to prevent this asynchronism by adapting surgical techniques, or treating this asynchronism with electrical therapy such as bivascular resynchronization.
Each patient in each group will perform, according to standard practice, an electrophysiological exploration with mapping of the heart using the CARTO system, a cardiac MRI and a 3-dimensional transthoracic echocardiography.
The follow-up of each patient takes place during a scheduled hospitalization as part of the care. Their participation in the study only lasts for the duration of the hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Inclusion Criteria in the Fallot group
- •Male or female patient aged 18,
- •Patient with Fallot Tetralogy operated.
- •nclusion Criteria in the Control group
- •Male or female patient aged 18,
- •Patient benefiting from electrophysiological exploration for a healthy heart arrhythmia,
- •Patient with a significant lack of heart disease.
排除标准
- •Exclusion Criteria in the Fallot group
- •Patient with associated left heart disease,
- •Patient with an acoustic window that does not allow for proper echocardiography,
- •Patient with contraindication to MRI,
- •Woman of childbearing age without effective contraception (HAS criteria) or Pregnant (ßHCG > 20 IU/l) or nursing woman.
- •Exclusion Criteria in the Control group
- •Patient with an acoustic window that does not allow proper echocardiography,
- •Patient with MRI contraindication,
- •Woman of childbearing age without effective contraception (HAS criteria) or Pregnant (ßHCG > 20 IU/l) or nursing woman,
- •Cardiac pathology detected during echocardiography.
研究组 & 干预措施
Fallot group
Patient with Fallot Tetralogy operated
干预措施: Electrophysiological exploration of the right ventricle (Other)
Control group
Patient benefiting from electrophysiological exploration for a healthy heart arrhythmia
干预措施: Electrophysiological exploration of the right ventricle (Other)
结局指标
主要结局
Comparison of electrical and mechanical activation by computational morphometry with temporal recalling to define electromechanical activation maps in healthy subjects and patients with Fallot tetralogy operated.
时间窗: Day 0
次要结局
- Strain longitudinal VD 3D at the 8 segments in %(Day 0)
- MR Analysis(Day 0)
- Area strain VD 3D global in %(Day 0)
- Intra-evaluator variability of 3D deformation parameters(Day 0)
- Comparison of 3D VD volume data between different populations(Day 0)
- Comparison of electrical activation maps based on anatomical data(Day 0)
- Strain circumferential VD 3D at the 8 segments in %(Day 0)
- Inter-evaluator variability of 3D deformation parameters(Day 0)