A Phase 2/3 interventional study of Implantation and testing of CRT and Implantation and testing of CRT in Congenital Heart Defects, sponsored by Competence Network for Congenital Heart Defects. Completed at 16 sites in 2 countries. Per ClinicalTrials.gov, last updated 2014-10-10.
Sponsored by Competence Network for Congenital Heart Defects · Phase 2/3, Interventional, and Treatment
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 who reject the randomization or cannot be paced with right ventricular pacing alone will be enrolled in group C with continuous biventricular pacing, which is the main group in this study. Optional: Immediately after implantation the patients are divided into group A and B (randomized, single blind (for the patient), cross-over design).
The treatment and the completing follow-up examination will take approximately 18 months and includes seven visits - one previous to the CRT and six at certain times afterward. At selected time intervals echocardiographic 3D and Tissue Doppler Imaging to evaluate the global and regional ventricular function are performed. Subjective quality of life assessment (questionnaire) will also be performed at the defined follow-up intervals, and if applicable (optional) also objective assessment of the physical performance (VO2 max).
55 patients also including children and adults with CHD are planned to be included in the study. The main target is to provide evidence of the effectiveness of CRT with biventricular stimulation in terms of improved ventricular function (ejection fraction and QRS interval).
1,007 studies on the registry are indexed under Heart Defects, Congenital; 257 are open to participants now.
This study's enrollment of 55 is close to the median of 60 across 524 interventional studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Competence Network for Congenital Heart Defects is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Implantation and testing of CRT
Device: Implantation and testing of CRT
IImplantation and testing of CRT
Device: Implantation and testing of CRT
Biventricular pacing for 12 weeks (CRT ON) followed by automatic rhythmicity or the original, conventional biventricular stimulation for 12 weeks (CRT OFF), then returning to biventricular pacing (CRT ON).
Automatic rhythmicity or original conventional biventricular stimulation for 12 weeks (CRT OFF) followed by biventricular pacing (CRT ON).
Ejection fraction
Time frame: 7 visits
QRS-interval
Time frame: 7 visits
Echocardiographic standard parameters (e.g. LVIDd. FS, RVIDd)
Time frame: 7 visits
Tissue Doppler echocardiography: dyssynchrony parameters, regional myocardiac function
Time frame: 7 visits
3D echocardiography:LV volumes, LVEF, Dyssynchrony index
Time frame: 7 visits
NT pro-BNP
Time frame: 7 visits
Spiroergometry: performance P (W/kg), incl. VO2,max
Time frame: 6 visits
Walking distance in 6 minutes
Time frame: 6 visits
Decrease of hospitalization
Time frame: 18 months
Decrease of ventricular and atrial arrhythmias
Time frame: 18 months
Prevention or postponement of heart transplantation
Time frame: 18 Months
Quality of life
Time frame: 6 visits
death
Time frame: 18 months
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Competence Network for Congenital Heart Defects