Postoperative Right Bundle Branch Block - Long-term Effect on the Right Ventricle in Children Operated for Ventricular Septal Defect
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Systolic function at rest measured by echocardiography
研究概览
简要总结
The most common congenital heart disease is the ventricular septal defect, and after surgical closure of a such defect, an arrythmia called the right bundle branch block, is very frequent. Therefore the aim of this study is to investigate if this group of patients has inferior outcomes compared to the group without this arrythmia after surgical closure and compared to a group of healthy control subjects.
All patients will be undergoing 1. exercise testing, 2. echocardiography, 3. echocardiography during exercise, and 4. MRI. The perspective is the ability to point out a group of patients with a possible need of further intervention, and additionally to increase the awareness of protecting the electrical system of the heart during the operation.
详细描述
Right bundle branch block is an exceedingly frequent complication in heart surgery, and especially in patients who have undergone surgical closure of a ventricular septal defect which is the most common congenital heart disease. How this bundle branch block effects the right ventricle of the heart on a long-term basis for this group of patients, is still unknown.
As a part of a PhD-study we therefore will try to illustrate this by echocardiography, MRI, exercise testing and other investigations 15 to 20 years after the surgical procedure. The study population thus consists of three different groups: 1. Patients whom undergone surgical closure of ventricular septal defect without postoperative right bundle branch block, 2. VSD-operated patients with right bundle branch block and 3. Healthy controls with no significant medical issues matched on age and sex. By carrying out the tests mentioned the right ventricles systolic function, diastolic function, the patients maximal exercise capacity and a lot of other parameters will be evaluated in the three groups of patients and compared amongst each other. The perspective therefore is the ability to point out a specific group of patients with an inferior outcome and with a possible need for further intervention. An additional perspective is to increase the awareness of protecting the bundle branch during the operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Operated for VSD in the period from 1990 to 1995 on Aarhus University Hospital Skejby
排除标准
- •No chart to be found
- •No EKG to be found
- •Known bundle branch block prior to the surgery
- •Other arrythmias
- •Use of ventriculotomy
- •Other disease than VSD
- •Pacemaker or other metallic implants
- •Pregnancy
结局指标
主要结局
Systolic function at rest measured by echocardiography
时间窗: All patients are tested only once about 20 years post to surgery
Dimensions of all 4 chambers, inspiratory collapse, and gradient over the tricuspidale valve is measured. Tricuspid Annulus Plane Systolic Excursion(TAPSE) and Tricuspid Annular peak Systolic Motion(TASM) is measured as well.
次要结局
- Maximal oxygen consumption during exercise(All patients are tested only once about 20 years post to surgery)
- Force-frequency-relation during exercise(All patients are tested only once about 20 years post to surgery)
- Diastolic function at rest measured by MRI(All patients are tested only once about 20 years post to surgery)
- Diastolic function at rest measured by echocardiography(All patients are tested only once about 20 years post to surgery)
- Systolic function at rest measured by MRI(All patients are tested only once about 20 years post to surgery)