Heart Septal Defects, Ventricular Clinical Trial
Official title:
Postoperative Right Bundle Branch Block - Long-term Effect on the Right Ventricle in Children Operated for Ventricular Septal Defect
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.
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.
;
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00390702 -
Safety and Effectiveness of the Nit-Occlud® Lê VSD Spiral Coil System
|
N/A | |
| Completed |
NCT00199771 -
Hypertonic Saline Dextran in Pediatric Cardiac Surgery
|
Phase 2 | |
| Completed |
NCT00583791 -
Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
|
N/A | |
| Completed |
NCT00005190 -
Reproduction and Survival After Cardiac Defect Repair
|
N/A | |
| Completed |
NCT00005546 -
Molecular Genetic Epidemiology of Three Cardiac Defects -SCOR in Pediatric Cardiovascular Disease
|
N/A | |
| Completed |
NCT00005322 -
Molecular Genetic Epidemiology of Endocardial Cushion Defects - SCOR in Pediatric Cardiovascular Disease
|
N/A | |
| Recruiting |
NCT00173186 -
Aortic Regurgitation After Surgical Repair of Outlet-Type Ventricular Septal Defect
|
N/A | |
| Withdrawn |
NCT01825369 -
Aberrations in Carnitine Homeostasis in Congenital Heart Disease With Increased Pulmonary Blood Flow
|
Phase 1 | |
| Completed |
NCT02361008 -
A Randomized Controlled Trial:Treatments on Infundibular Ventricular Septal Defect
|
N/A | |
| Terminated |
NCT00113698 -
Angiotensin Converting Enzyme Inhibition in Children With Mitral Regurgitation
|
Phase 3 | |
| Completed |
NCT00000470 -
Infant Heart Surgery: Central Nervous System Sequelae of Circulatory Arrest
|
Phase 3 | |
| Recruiting |
NCT00006272 -
Study of Energy Expenditure in Infants With Ventricular Septal Defects
|
N/A |