Skip to content

Right Bundle Branch Block After Surgical Closure of Ventricular Septal Defect

Postoperative Right Bundle Branch Block - Long-term Effect on the Right Ventricle in Children Operated for Ventricular Septal Defect

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01480908
Enrollment
60
Registered
2011-11-29
Start date
2011-06-30
Completion date
2014-12-31
Last updated
2014-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bundle-Branch Block, Heart Septal Defects, Ventricular

Keywords

Right bundle branch block, Ventricular septal defect, Echocardiography, MRI, Exercise testing

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.

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.

Interventions

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.

PROCEDUREEchocardiography during exercise

TASM is measured during exercise along with pulse measurements to evaluate the force-frequency-relation.

PROCEDUREMRI 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.

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

Aarhus University Hospital Skejby
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Operated for VSD in the period from 1990 to 1995 on Aarhus University Hospital Skejby

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Systolic function at rest measured by echocardiographyAll patients are tested only once about 20 years post to surgeryDimensions 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.

Secondary

MeasureTime frameDescription
Maximal oxygen consumption during exerciseAll patients are tested only once about 20 years post to surgeryMaximal oxygen consumption is measured during on a bicycle. Prior to the test a spirometry is performed to rull out potentiel diffenrences in pulmonary function between the cohorts. During the test pulse, blood pressure, saturation, and EKG are monitored. Ventilatory volume, oxygen consumption and carbondioxide excretion are measured. Anaerobic threshold is calculated at the end of the test.
Force-frequency-relation during exerciseAll patients are tested only once about 20 years post to surgeryTASM is measured during exercise along with pulse measurements to evaluate the force-frequency-relation.
Diastolic function at rest measured by MRIAll patients are tested only once about 20 years post to surgeryDimensions 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.
Diastolic function at rest measured by echocardiographyAll patients are tested only once about 20 years post to surgeryDimensions 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.
Systolic function at rest measured by MRIAll patients are tested only once about 20 years post to surgeryDimensions 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026