Right Bundle Branch Block After Surgical Closure of Ventricular Septal Defect

NCT01480908 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-12-03

No results posted yet for this study

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

Interventions

PROCEDURE

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.

PROCEDURE

Echocardiography during exercise

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

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Aarhus University Hospital Skejby

    collaborator OTHER
  • University of Aarhus

    lead OTHER

Principal Investigators

  • Vibeke Hjortdal, MD, DMSc, Prof. · Dept. of Cardiothoracic surgery, Aarhus Universitetshospital Skejby

  • Michael R. Schmidt, MD, PhD · Dept. of Cardiology, Aarhus University Hospital Skejby

  • Steffen Ringgaard, Physics, PhD · Dept. MRI, Aarhus University Hospital Skejby

  • Andrew Redington, MD, DMSc, Prof. · Dept. of Cardiology, The Hospital for Sick Children, Toronto

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-10-31
Completion
2014-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01480908 on ClinicalTrials.gov