Status:
COMPLETED
Cardiac Resynchronization Therapy in Congenital Heart Defects
Lead Sponsor:
Competence Network for Congenital Heart Defects
Conditions:
Congenital Heart Defects
Eligibility:
All Genders
Phase:
PHASE2
PHASE3
Brief Summary
The objective of this multicentre prospective therapeutic study is to evaluate the effects of CRT on the right and left ventricular function of patients with CHD in the medium and long term. Patients ...
Eligibility Criteria
Inclusion
- Patients with congenital heart defects
- Heart failure of the Morphologically right or left system ventricle with an absolute ejection fraction of \< 40% in the failed ventricle
- NYHA classes II-IV
- Optimal drug therapy for heart failure according to the ESC guidelines
- QRS interval ≥ 120 ms (demonstrated in at least two relevant ECG derivations, depending on existing bundle branch block symptoms)
- Patients with chronic stimulation of the subpulmonary ventricle by a 1- or 2-ventricle pacemaker, which also meets the above-mentioned criteria
- Patients with morphologically right ventricle in system position and significant insufficiency of the systemic atrioventricular valve, if they also meet the criteria listed above
Exclusion
- PTCA, cardiomyoplasty or myocardial infarction / unstable angina pectoris or cerebral insult within the 6 weeks preceding the planned cardiac resynchronisation therapy
- Patients with pulmonary hypertension / Eisenmenger's syndrome
- Life expectancy \< 1 year due to a non-cardiac disease
- Anticipated poor compliance by the patient
- Pregnancy and breastfeeding
- Known or persistent abuse of prescription medicines, recreational drugs or alcohol
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00450684
Start Date
May 1 2007
End Date
September 1 2013
Last Update
October 10 2014
Active Locations (16)
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1
AKH Wien, Klinische Abteilung für Pädiatrische Kardiologie
Vienna, Austria, A-1090
2
Universitätsklinikum Münster, Klinik für angeborene (EMAH) und erworbene Herzfehler
Münster, North Rhine-Westphalia, Germany, D-48149
3
Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Pädiatrische Kardiologie
Halle, Saxony-Anhalt, Germany, D-06120
4
Uniklinik RWTH Aachen, AÖR, Klinik für Kinderkardiologie
Aachen, Germany, D-52074