Congenital Heart Defects Clinical Trial
Official title:
Cardiac Resynchronization Therapy in Heart Failure Patients With Congenital Heart Defects
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).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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