Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-04-04 @ 12:10 AM
Study NCT ID:
NCT00536432
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
2007-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Re-intervention in Infants and Small Children After Correction of Tetralogy of Fallot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013771', 'term': 'Tetralogy of Fallot'}], 'ancestors': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-05', 'studyFirstSubmitDate': '2007-09-26', 'studyFirstSubmitQcDate': '2007-09-26', 'lastUpdatePostDateStruct': {'date': '2012-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Tetralogy of Fallot']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.kompetenznetz-ahf.de', 'label': 'click here for more information about the Competence Network for Congenital Heart Defects'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nPulmonary 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'children, \\<8 years, with tetralogy of Fallot', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent of the patient's legal representatives\n* Patients with tetralogy of Fallot (including pulmonary atresia with vsd) after corrective operation\n* Patients \\< 8 years with corrective surgery and necessary re-intervention (e.g.cardiac catheter intervention or re-operation )\n\nExclusion Criteria:\n\n* DORV (if there is another VSD than subaortic)\n* Associated severe heart defects (e. g. AV canal)\n* Other clinically relevant diseases, such as malignant tumor (in the investigating physician's assessment)\n* MRI contraindication, e.g. cardiac pacemaker, implanted neurostimulators and other magnetizable foreign bodies"}, 'identificationModule': {'nctId': 'NCT00536432', 'briefTitle': 'Early Re-intervention in Infants and Small Children After Correction of Tetralogy of Fallot', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Competence Network for Congenital Heart Defects'}, 'officialTitle': 'Early Re-intervention in Infants and Small Children After Correction of Tetralogy of Fallot: Prospective Analysis of Myocardial Benefit Using Cardiac MRI and Echocardiography', 'orgStudyIdInfo': {'id': 'MP 4.2'}}, 'contactsLocationsModule': {'locations': [{'zip': 'D-79106', 'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Freiburg, Klinik III Päd. Kardiologie', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': 'D-72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Tuebingen, Klinik für Kinderheilkunde und Jugendmedizin', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': 'D-80636', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum Muenchen', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': 'D-30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover, Pädiatrische Kardiologie und Intensivmedizin', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': 'D-32545', 'city': 'Bad Oeynhausen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Herz- und Diabeteszentrum Nordrhein-Westfalen', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'zip': 'D-47137', 'city': 'Duisburg', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Herzzentrum Duisburg, Kinderkardiologie', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'zip': 'D-45122', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Universitätsklinikum Essen, Klinik für Kinderkardiologie', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': 'D-48149', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Universitätsklinikum Muenster, Klinik für Kinderkardiologie', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': 'D-53757', 'city': 'Sankt Augustin', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Deutsches Kinderherzzentrum St. Augustin', 'geoPoint': {'lat': 50.77538, 'lon': 7.197}}, {'zip': 'D-66421', 'city': 'Homburg/Saar', 'state': 'Saarland', 'country': 'Germany', 'facility': 'Universitätsklinikum des Saarlandes, Klinik für Pädiatrische Kardiologie'}, {'zip': 'D-04289', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Herzzentrum Leipzig, Klinik für Kinderkardiologie', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': 'D-24105', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik für Kinderkardiologie', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': 'D-13353', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'D-13353', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Universitätsklinikum Charite, Campus Virchow-Klinikum, Otto-Heubner-Centrum für Kinder- und Jugendmedizin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Samir Sarikouch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medizinische Hochschule Hannover, Lower Saxony'}, {'name': 'Philipp Beerbaum, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Evelina Children's Hospital, Guy's and St. Thomas Foundation Trust, Interdisciplinary Medical Imaging Group, King's College London"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Competence Network for Congenital Heart Defects', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}]}}}