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

Early Re-intervention in Infants and Small Children After Correction of Tetralogy of Fallot: Prospective Analysis of Myocardial Benefit Using Cardiac MRI and Echocardiography

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 93

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, D-13353
    • Deutsches Herzzentrum Berlin
  • Berlin, Germany, D-13353
    • Universitätsklinikum Charite, Campus Virchow-Klinikum, Otto-Heubner-Centrum für Kinder- und Jugendmedizin
  • Baden-Wuerttemberg
    • Freiburg, Baden-Wuerttemberg, Germany, D-79106
      • Universitätsklinikum Freiburg, Klinik III Päd. Kardiologie
    • Tuebingen, Baden-Wuerttemberg, Germany, D-72076
      • Universitätsklinikum Tuebingen, Klinik für Kinderheilkunde und Jugendmedizin
  • Bavaria
    • Munich, Bavaria, Germany, D-80636
      • Deutsches Herzzentrum Muenchen
  • Lower Saxony
    • Hannover, Lower Saxony, Germany, D-30625
      • Medizinische Hochschule Hannover, Pädiatrische Kardiologie und Intensivmedizin
  • North Rhine-Westphalia
    • Bad Oeynhausen, North Rhine-Westphalia, Germany, D-32545
      • Herz- und Diabeteszentrum Nordrhein-Westfalen
    • Duisburg, North Rhine-Westphalia, Germany, D-47137
      • Herzzentrum Duisburg, Kinderkardiologie
    • Essen, North Rhine-Westphalia, Germany, D-45122
      • Universitätsklinikum Essen, Klinik für Kinderkardiologie
    • Muenster, North Rhine-Westphalia, Germany, D-48149
      • Universitätsklinikum Muenster, Klinik für Kinderkardiologie
    • Sankt Augustin, North Rhine-Westphalia, Germany, D-53757
      • Deutsches Kinderherzzentrum St. Augustin
  • Saarland
    • Homburg/Saar, Saarland, Germany, D-66421
      • Universitätsklinikum des Saarlandes, Klinik für Pädiatrische Kardiologie
  • Saxony
    • Leipzig, Saxony, Germany, D-04289
      • Herzzentrum Leipzig, Klinik für Kinderkardiologie
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, D-24105
      • Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik für Kinderkardiologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 7 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

children, <8 years, with tetralogy of Fallot

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Competence Network for Congenital Heart Defects
• Collaborators: German Federal Ministry of Education and Research
• Investigators: Principal Investigator: Samir Sarikouch, MD, Medizinische Hochschule Hannover, Lower Saxony

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: September 26, 2007
• First Submitted That Met QC Criteria: September 26, 2007
• First Posted (ESTIMATE): September 27, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): June 6, 2012
• Last Update Submitted That Met QC Criteria: June 5, 2012
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Tetralogy of Fallot
• Other Study ID Numbers: MP 4.2