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

NCT ID: NCT00536432

Last Updated: 2012-06-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 93 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2012-06-30

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.

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.

Conditions

Tetralogy of Fallot

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role: collaborator

Competence Network for Congenital Heart Defects

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Samir Sarikouch, MD

Role: PRINCIPAL_INVESTIGATOR

Medizinische Hochschule Hannover, Lower Saxony

Philipp Beerbaum, MD

Role: STUDY_CHAIR

Evelina Children's Hospital, Guy's and St. Thomas Foundation Trust, Interdisciplinary Medical Imaging Group, King's College London

Locations

Universitätsklinikum Freiburg, Klinik III Päd. Kardiologie

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Universitätsklinikum Tuebingen, Klinik für Kinderheilkunde und Jugendmedizin

Tübingen, Baden-Wurttemberg, Germany

Deutsches Herzzentrum Muenchen

Munich, Bavaria, Germany

Medizinische Hochschule Hannover, Pädiatrische Kardiologie und Intensivmedizin

Hanover, Lower Saxony, Germany

Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, North Rhine-Westphalia, Germany

Herzzentrum Duisburg, Kinderkardiologie

Duisburg, North Rhine-Westphalia, Germany

Universitätsklinikum Essen, Klinik für Kinderkardiologie

Essen, North Rhine-Westphalia, Germany

Universitätsklinikum Muenster, Klinik für Kinderkardiologie

Münster, North Rhine-Westphalia, Germany

Deutsches Kinderherzzentrum St. Augustin

Sankt Augustin, North Rhine-Westphalia, Germany

Universitätsklinikum des Saarlandes, Klinik für Pädiatrische Kardiologie

Homburg/Saar, Saarland, Germany

Herzzentrum Leipzig, Klinik für Kinderkardiologie

Leipzig, Saxony, Germany

Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik für Kinderkardiologie

Kiel, Schleswig-Holstein, Germany

Deutsches Herzzentrum Berlin

Berlin, State of Berlin, Germany

Universitätsklinikum Charite, Campus Virchow-Klinikum, Otto-Heubner-Centrum für Kinder- und Jugendmedizin

Berlin, State of Berlin, Germany

Countries

Germany

Related Links

http://www.kompetenznetz-ahf.de

click here for more information about the Competence Network for Congenital Heart Defects

Other Identifiers

MP 4.2

Identifier Type: -

Identifier Source: org_study_id