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

NCT00536432 | Completed

• 1 other identifier: MP 4.2
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 14

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.

Conditions

Tetralogy of Fallot

Eligibility Criteria

• Age: Up to 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

children, \<8 years, with tetralogy of Fallot

You may qualify if:

• 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 )

You may not qualify if:

• 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

Sponsors & Collaborators

• Competence Network for Congenital Heart Defects: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (14)

Universitätsklinikum Freiburg, Klinik III Päd. Kardiologie

Freiburg im Breisgau, Baden-Wurttemberg, D-79106, Germany

Location

Universitätsklinikum Tuebingen, Klinik für Kinderheilkunde und Jugendmedizin

Tübingen, Baden-Wurttemberg, D-72076, Germany

Location

Deutsches Herzzentrum Muenchen

Munich, Bavaria, D-80636, Germany

Location

Medizinische Hochschule Hannover, Pädiatrische Kardiologie und Intensivmedizin

Hanover, Lower Saxony, D-30625, Germany

Location

Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, North Rhine-Westphalia, D-32545, Germany

Location

Herzzentrum Duisburg, Kinderkardiologie

Duisburg, North Rhine-Westphalia, D-47137, Germany

Location

Universitätsklinikum Essen, Klinik für Kinderkardiologie

Essen, North Rhine-Westphalia, D-45122, Germany

Location

Universitätsklinikum Muenster, Klinik für Kinderkardiologie

Münster, North Rhine-Westphalia, D-48149, Germany

Location

Deutsches Kinderherzzentrum St. Augustin

Sankt Augustin, North Rhine-Westphalia, D-53757, Germany

Location

Universitätsklinikum des Saarlandes, Klinik für Pädiatrische Kardiologie

Homburg/Saar, Saarland, D-66421, Germany

Location

Herzzentrum Leipzig, Klinik für Kinderkardiologie

Leipzig, Saxony, D-04289, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik für Kinderkardiologie

Kiel, Schleswig-Holstein, D-24105, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, State of Berlin, D-13353, Germany

Location

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

Berlin, State of Berlin, D-13353, Germany

Location

Related Links

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

MeSH Terms

Conditions

Tetralogy of Fallot

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Samir Sarikouch, MD

  Medizinische Hochschule Hannover, Lower Saxony

  PRINCIPAL INVESTIGATOR

• Philipp Beerbaum, MD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 26, 2007
• First Posted: September 27, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: June 1, 2012
• Last Updated: June 6, 2012

Record last verified: 2010-10

Locations

DE (14)