Right Bundle Branch Block After Surgical Closure of Ventricular Septal Defect

NCT01480908 | Completed

• 1 other identifier: VSDRBBBB-RV
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bundle-Branch Block; Heart Septal Defects, Ventricular

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Systolic function at rest measured by echocardiography

  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.

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

Secondary Outcomes (5)

• Maximal oxygen consumption during exercise

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

• Force-frequency-relation during exercise

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

• Diastolic function at rest measured by MRI

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

• Diastolic function at rest measured by echocardiography

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

• Systolic function at rest measured by MRI

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

Study Arms (3)

VSD, +Right bundle branch block

EXPERIMENTAL

Patients undergone surgical closure of ventricular septal defect and have a postoperative right bundle branch block, about 20 patients

Procedure: Echocardiography at rest; Procedure: Echocardiography during exercise; Procedure: MRI at rest; Procedure: Exercise testing

VSD, -Right bundle branch block

EXPERIMENTAL

Patients undergone surgical closure of ventricular septal defect and does not have a postoperative right bundle branch block, about 20 patients

Procedure: Echocardiography at rest; Procedure: Echocardiography during exercise; Procedure: MRI at rest; Procedure: Exercise testing

Control

EXPERIMENTAL

Healthy control subjects, about 20 patients

Procedure: Echocardiography at rest; Procedure: Echocardiography during exercise; Procedure: MRI at rest; Procedure: Exercise testing

Interventions

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.

Control; VSD, +Right bundle branch block; VSD, -Right bundle branch block

Echocardiography during exercise PROCEDURE

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

Control; VSD, +Right bundle branch block; VSD, -Right bundle branch block

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.

Control; VSD, +Right bundle branch block; VSD, -Right bundle branch block

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.

Control; VSD, +Right bundle branch block; VSD, -Right bundle branch block

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital Skejby: collaborator

Study Sites (1)

Aarhus University Hospital Skejby

Aarhus, Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Bundle-Branch Block; Heart Septal Defects, Ventricular

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Vibeke Hjortdal, MD, DMSc, Prof.

  Dept. of Cardiothoracic surgery, Aarhus Universitetshospital Skejby

  STUDY CHAIR

• Michael R. Schmidt, MD, PhD

  Dept. of Cardiology, Aarhus University Hospital Skejby

  STUDY DIRECTOR

• Steffen Ringgaard, Physics, PhD

  Dept. MRI, Aarhus University Hospital Skejby

  STUDY DIRECTOR

• Andrew Redington, MD, DMSc, Prof.

  Dept. of Cardiology, The Hospital for Sick Children, Toronto

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: November 29, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2013-08

Locations

DK (1)