Right Bundle Branch Block After Surgical Closure of Ventricular Septal Defect
| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | November 16, 2011 | ||||||||||||||||
| Last Updated Date | September 11, 2012 | ||||||||||||||||
| Start Date ICMJE | June 2011 | ||||||||||||||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Systolic function at rest measured by echocardiography [ Time Frame: All patients are tested only once about 20 years post to surgery ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT01480908 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Right Bundle Branch Block After Surgical Closure of Ventricular Septal Defect | ||||||||||||||||
| Official Title ICMJE | Postoperative Right Bundle Branch Block - Long-term Effect on the Right Ventricle in Children Operated for Ventricular Septal Defect | ||||||||||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||||||||||
| Estimated Completion Date | June 2014 | ||||||||||||||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||
| Ages | Not Provided | ||||||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Denmark | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT01480908 | ||||||||||||||||
| Other Study ID Numbers ICMJE | VSDRBBBB-RV | ||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||
| Responsible Party | University of Aarhus | ||||||||||||||||
| Study Sponsor ICMJE | University of Aarhus | ||||||||||||||||
| Collaborators ICMJE | Aarhus University Hospital | ||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of Aarhus | ||||||||||||||||
| Verification Date | September 2012 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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