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NCT Number: NCT01480908

Right Bundle Branch Block After Surgical Closure of 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.

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Key information

Conditions

Bundle-Branch Block Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Block Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Ventricular Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital Skejby

Aarhus, Aarhus N, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiography at rest

Procedure

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

Procedure

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

MRI at rest

Procedure

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

Procedure

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.

Primary outcomes

  1. Systolic function at rest measured by echocardiography

    Time frame: All patients are tested only once about 20 years post to surgery

    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.

Secondary outcomes

  1. Maximal oxygen consumption during exercise

    Time frame: All patients are tested only once about 20 years post to surgery

    Maximal 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.

  2. Force-frequency-relation during exercise

    Time frame: All patients are tested only once about 20 years post to surgery

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

  3. Diastolic function at rest measured by MRI

    Time frame: All patients are tested only once about 20 years post to surgery

    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.

  4. Diastolic function at rest measured by echocardiography

    Time frame: All patients are tested only once about 20 years post to surgery

    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.

  5. Systolic function at rest measured by MRI

    Time frame: All patients are tested only once about 20 years post to surgery

    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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital Skejby

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 29, 2011
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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