Right Bundle Branch Block After Surgical Closure of Ventricular Septal Defect

University of Aarhus

Status: Completed

Conditions: Heart Septal Defects, Ventricular; Bundle-Branch Block

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01480908

VSDRBBBB-RV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 3 patient groups

VSD, +Right bundle branch block

Experimental group

Description:

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

Treatment:

Procedure: Echocardiography at rest

Procedure: Exercise testing

Procedure: Echocardiography during exercise

Procedure: MRI at rest

VSD, -Right bundle branch block

Experimental group

Description:

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

Treatment:

Procedure: Echocardiography at rest

Procedure: Exercise testing

Procedure: Echocardiography during exercise

Procedure: MRI at rest

Control

Experimental group

Description:

Healthy control subjects, about 20 patients

Treatment:

Procedure: Echocardiography at rest

Procedure: Exercise testing

Procedure: Echocardiography during exercise

Procedure: MRI at rest