gms | German Medical Science

Introduction: A multicenter, controlled and prospective studies have not been performed yet and is now planed within the the Competence Network for Congenital Heart Defects.

Objective: Patients with congenital heart disease with heart failure and detectable asynchrony will be prospectively randomized for cross-over multicenter study. Inclusion criteria: Patients will be included who have congenital heart disease, failure of the systemic ventricle independent of the chamber morphology, ejection fraction of the systemic ventricle <45%, NYHA >/= II, QRS - duration > 150 ms in 2 ECG and detection of interventricular asynchrony by conventional and tissue Doppler strain methods. Patients with coronary heart disease, trisomy 21, univentricular heart without Fontan operation, patients with Eisenmenger syndrome and pregnant patients will be excluded.

Control intervention: Four weeks after implantation biventricular stimulation will be switched off and only RV pacing will be programmed without knowledge of the patient (group A, n=35). In the other patients the CRT system with biventricular pacing will remain on for 4 weeks (group B, n=35). After 4 weeks cross-over between groups A and B is performed. For those patients who do not tolerate the RV pacing alone or do not agree to participate in the cross-over intervention the CRT system will be kept on (group C, n=30).

Primary efficacy endpoints: Improvement of VO2 max, EF of systemic ventricle and decrease of QRS duration. Six-minute walk test is considered for those with NYHA III-IV.

Conclusion: Participation in this multicenter study would be appreciated and will be honoured with a defined sum as compensation for collecting data and monitoring the patients after CRT.