Right Bundle Branch Block After Surgical Closure of Ventricular Septal Defect
NCT01480908 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2014-12-03
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.
Conditions
- Bundle-Branch Block
- Heart Septal Defects, Ventricular
Interventions
- PROCEDURE
-
Echocardiography at rest
Dimensions of all 4 chambers, inspiratory collapse, and gradient over the tricuspid valve is measured. Tricuspid Annulus Plane Systolic Excursion(TAPSE) and Tricuspid Annular peak Systolic Motion(TASM) is measured as well.
- PROCEDURE
-
Echocardiography during exercise
TASM is measured during exercise along with pulse measurements to evaluate the force-frequency-relation.
- PROCEDURE
-
MRI at rest
Dimensions of all 4 chambers are measured at end-systole and end-diastole. Blood flow measurements through the aortic and the pulmonary valve are made as well. No use of contrast.
- PROCEDURE
-
Exercise testing
Maximal oxygen consumption is measured during on a bicycle. Prior to the test a spirometry is performed to rull out potential differences in pulmonary function between the cohorts. During the test pulse, blood pressure, saturation, and EKG are monitored. Ventilatory volume, oxygen consumption and carbon dioxide excretion are measured. Anaerobic threshold is calculated at the end of the test.
Sponsors & Collaborators
-
Aarhus University Hospital Skejby
collaborator OTHER -
University of Aarhus
lead OTHER
Principal Investigators
-
Vibeke Hjortdal, MD, DMSc, Prof. · Dept. of Cardiothoracic surgery, Aarhus Universitetshospital Skejby
-
Michael R. Schmidt, MD, PhD · Dept. of Cardiology, Aarhus University Hospital Skejby
-
Steffen Ringgaard, Physics, PhD · Dept. MRI, Aarhus University Hospital Skejby
-
Andrew Redington, MD, DMSc, Prof. · Dept. of Cardiology, The Hospital for Sick Children, Toronto
Study Design
- Allocation
- NON_RANDOMIZED
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-06-30
- Primary Completion
- 2014-10-31
- Completion
- 2014-12-31
Countries
- Denmark
Study Locations
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