Right Bundle Branch Block After Surgical Closure of Ventricular Septal Defect
NCT ID: NCT01480908
Last Updated: 2014-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2011-06-30
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
VSD, +Right bundle branch block
Patients undergone surgical closure of ventricular septal defect and have a postoperative right bundle branch block, about 20 patients
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.
Echocardiography during exercise
TASM is measured during exercise along with pulse measurements to evaluate the force-frequency-relation.
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.
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.
VSD, -Right bundle branch block
Patients undergone surgical closure of ventricular septal defect and does not have a postoperative right bundle branch block, about 20 patients
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.
Echocardiography during exercise
TASM is measured during exercise along with pulse measurements to evaluate the force-frequency-relation.
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.
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.
Control
Healthy control subjects, about 20 patients
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.
Echocardiography during exercise
TASM is measured during exercise along with pulse measurements to evaluate the force-frequency-relation.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Echocardiography during exercise
TASM is measured during exercise along with pulse measurements to evaluate the force-frequency-relation.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aarhus University Hospital Skejby
OTHER
University of Aarhus
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vibeke Hjortdal, MD, DMSc, Prof.
Role: STUDY_CHAIR
Dept. of Cardiothoracic surgery, Aarhus Universitetshospital Skejby
Michael R. Schmidt, MD, PhD
Role: STUDY_DIRECTOR
Dept. of Cardiology, Aarhus University Hospital Skejby
Steffen Ringgaard, Physics, PhD
Role: STUDY_DIRECTOR
Dept. MRI, Aarhus University Hospital Skejby
Andrew Redington, MD, DMSc, Prof.
Role: STUDY_DIRECTOR
Dept. of Cardiology, The Hospital for Sick Children, Toronto
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aarhus University Hospital Skejby
Aarhus, Aarhus N, Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VSDRBBBB-RV
Identifier Type: -
Identifier Source: org_study_id