Status:
COMPLETED
Follow up of Post-repair Tetralogy of Fallot
Lead Sponsor:
Competence Network for Congenital Heart Defects
Collaborating Sponsors:
German Federal Ministry of Education and Research
Conditions:
Tetralogy of Fallot
Eligibility:
All Genders
8+ years
Brief Summary
Tetralogy of Fallot is the most frequent complex congenital heart malformation. Over the past five decades, surgical repair has been performed with respectable results. However, relevant postoperative...
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 tol...
Eligibility Criteria
Inclusion
- Written consent of the patient and/or the patient's legal representative
- Patients with tetralogy of Fallot (including pulmonary atresia with extreme form of VSD ) after corrective operation
- The corrective intervention has to date back to at least one year before study inclusion
- Ergospirometry and MRI examination can be carried out on an outpatient basis (i. e. patients are normally older than 8 years)
- Patients are not selected according to functional status, i. e. in terms of potentially necessary reintervention measures (e. g. cardiac catheter intervention, pulmonary valve replacement)
Exclusion
- Lack of consent
- Tetralogy of Fallot or pulmonary atresia with VSD without corrective operation (or corrective operation that dates back to less than one year before)
- Pulmonary valve agenesia, DORV (if there is a distinct discontinuity between mitral valve and aortic valve)
- Associated severe heart defects (e. g. AV canal)
- Other clinically relevant diseases, such as malignant tumour or florid diseases (in the investigating physician's assessment)
- Patient is not able to perform ergospirometry (bicycle/treadmill) or contraindication exists
- Absolute MRI contraindication, e.g. cardiac pacemaker
- Pregnant and breast-feeding patients
- Lack of cardiac catheter findings (or MRI) before initial operation -
Key Trial Info
Start Date :
January 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT00266188
Start Date
January 1 2005
End Date
June 1 2008
Last Update
September 21 2011
Active Locations (14)
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1
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany, D-72076
2
Deutsches Herzzentrum Muenchen
Munich, Bavaria, Germany, D-80636
3
Herzzentrum Hamburg, UKE
Hamburg, Hamburg, Germany, D-29246
4
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany, D-30625