Early Re-intervention in Infants and Small Children After Correction of Tetralogy of Fallot

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00536432
Recruitment Status : Completed
First Posted : September 27, 2007
Last Update Posted : June 6, 2012
German Federal Ministry of Education and Research
Information provided by:
Competence Network for Congenital Heart Defects

Brief Summary:

Tetralogy of Fallot is one of the most frequent congenital heart malformations. In many cases re-interventions, surgical or catheter-based, are necessary after the repair of tetralogy of Fallot in infancy. At present, informations in the literature about the myocardial benefit and the timing of re-interventions are missing in this age group. On the other hand, Fallot patients are dependent on solid criteria for re-interventions, because further interventions like replacement of the pulmonary valve or balloon dilatations of peripheral pulmonary stenoses are common.

The objective of this study is to assess the benefit of such interventions for the right ventricular function. By performing extensive standardised examinations (including MRI, echocardiography, tissue Doppler,,3D-echocardiography, holter monitoring and quality of life assessments) before and 6 to 9 months after the re-intervention data of the right ventricular function are collected. Based on these quantitative data predictive parameters concerning the right ventricular recovery and information about the time of re-intervention should be determined.

Condition or disease
Tetralogy of Fallot

Detailed Description:

In the repair of tetralogy of Fallot, pulmonary insufficiency used to be tacitly accepted as a result of extensive transannular patching (TAP) and considered unobjectionable. In fact, this is well tolerated during the first postoperative years, but today there is increasing evidence that the resulting chronic volume stress to the right ventricle is harmful on the long run, in particular if there are stenoses of the pulmonary artery in addition. Such stenoses, partly due to distortions after shunt surgery, together with pulmonary insufficiency, lead to a combined volume and pressure load of the right ventricle. The chronic volume stress results in a decrease in biventricular function and exercise tolerance, associated with increasing electrical instability with frequent, mostly ventricular, dysrhythmias. This constellation brings about a significantly increased risk of cardiac death.

Pulmonary valve replacement can improve haemodynamics, exercise tolerance and dysrhythmia. However, it is still unclear, which criteria best indicate the need for re-intervention, such as balloon dilatations of peripheral pulmonary stenoses, and what may be the best point in time in infancy.

The objective of this study is to assess the effectiveness of such interventions to the right ventricular function in small children. The data obtained are supposed to determine predictive parameters of the right ventricular recovery and to help to establish criteria for the necessity and time of re-intervention.

Study Type : Observational
Actual Enrollment : 93 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Re-intervention in Infants and Small Children After Correction of Tetralogy of Fallot: Prospective Analysis of Myocardial Benefit Using Cardiac MRI and Echocardiography
Study Start Date : September 2007
Actual Primary Completion Date : September 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
children, <8 years, with tetralogy of Fallot

Inclusion Criteria:

  • Written informed consent of the patient's legal representatives
  • Patients with tetralogy of Fallot (including pulmonary atresia with vsd) after corrective operation
  • Patients < 8 years with corrective surgery and necessary re-intervention (e.g.cardiac catheter intervention or re-operation )

Exclusion Criteria:

  • DORV (if there is another VSD than subaortic)
  • Associated severe heart defects (e. g. AV canal)
  • Other clinically relevant diseases, such as malignant tumor (in the investigating physician's assessment)
  • MRI contraindication, e.g. cardiac pacemaker, implanted neurostimulators and other magnetizable foreign bodies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00536432

Universitätsklinikum Freiburg, Klinik III Päd. Kardiologie
Freiburg, Baden-Wuerttemberg, Germany, D-79106
Universitätsklinikum Tuebingen, Klinik für Kinderheilkunde und Jugendmedizin
Tuebingen, Baden-Wuerttemberg, Germany, D-72076
Deutsches Herzzentrum Muenchen
Munich, Bavaria, Germany, D-80636
Medizinische Hochschule Hannover, Pädiatrische Kardiologie und Intensivmedizin
Hannover, Lower Saxony, Germany, D-30625
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, North Rhine-Westphalia, Germany, D-32545
Herzzentrum Duisburg, Kinderkardiologie
Duisburg, North Rhine-Westphalia, Germany, D-47137
Universitätsklinikum Essen, Klinik für Kinderkardiologie
Essen, North Rhine-Westphalia, Germany, D-45122
Universitätsklinikum Muenster, Klinik für Kinderkardiologie
Muenster, North Rhine-Westphalia, Germany, D-48149
Deutsches Kinderherzzentrum St. Augustin
Sankt Augustin, North Rhine-Westphalia, Germany, D-53757
Universitätsklinikum des Saarlandes, Klinik für Pädiatrische Kardiologie
Homburg/Saar, Saarland, Germany, D-66421
Herzzentrum Leipzig, Klinik für Kinderkardiologie
Leipzig, Saxony, Germany, D-04289
Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik für Kinderkardiologie
Kiel, Schleswig-Holstein, Germany, D-24105
Deutsches Herzzentrum Berlin
Berlin, Germany, D-13353
Universitätsklinikum Charite, Campus Virchow-Klinikum, Otto-Heubner-Centrum für Kinder- und Jugendmedizin
Berlin, Germany, D-13353
Sponsors and Collaborators
Competence Network for Congenital Heart Defects
German Federal Ministry of Education and Research
Principal Investigator: Samir Sarikouch, MD Medizinische Hochschule Hannover, Lower Saxony
Study Chair: Philipp Beerbaum, MD Evelina Children's Hospital, Guy's and St. Thomas Foundation Trust, Interdisciplinary Medical Imaging Group, King's College London

Additional Information: Identifier: NCT00536432     History of Changes
Other Study ID Numbers: MP 4.2
First Posted: September 27, 2007    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: October 2010

Additional relevant MeSH terms:
Tetralogy of Fallot
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities