About this trial
This study aims to evaluate the real-world effects of cardiac resynchronization therapy (CRT) in adult patients with congenital heart disease (ACHD). Specifically, it seeks to determine whether CRT improves clinical outcomes in this unique patient population and to identify factors associated with a favorable response to therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ACHD patients who underwent CRT implantation
Disqualifiers
Less than 18 years old on the moment of CRT implantation
Patient objection to the use of retrospective data
Trial population
All adult congenital heart disease patients who received cardiac resynchronization therapy.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Cardiac resynchronization therapy
DeviceCardiac resynchronization therapy pacemaker or defibrillator with a transvenous or epicardial systemic ventricle lead
Treatment groups
Trial outcomes
Primary outcomes
QRS duration
Evaluation of the longitudinal effect of CRT on the duration (in ms) of the QRS interval on surface ECG
Systemic ventricle function class
Evaluation of the longitudinal effect of CRT on the echocardiographic functional classification of the systemic ventricle (i.e., normal, mildly reduced, moderately reduced, severely reduced)
NYHA functional class
Evaluation of the longitudinal effect of CRT on the NYHA functional classification (i.e., Class I, II, III, IV)
Secondary outcomes
Clinical - Mortality
Death from any cause during the study period
Clinical - Heart failure hospitalization
At least one overnight stay with cardiac decompensation as the primary reason for hospitalization
Clinical - CV hospitalization other than HF
At least one overnight stay due to any primary cardiovascular reason, excluding heart failure
Clinical - Urgent heart failure visit
An unplanned medical contact requiring decongestion, but no overnight stay in the hospital
Sponsors and contacts
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