NCT Number: NCT06969924
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Leiden, South Holland, 2333ZA, Netherlands
Location status: Recruiting
Anastasia D. Egorova, MD, PhD
CONTACT
Bert A.C. Zwaenepoel, MD
SUB_INVESTIGATOR
Ralph M.L. Neijenhuis, MD
SUB_INVESTIGATOR
Cardiac resynchronization therapy (CRT) is well-established in acquired heart failure, but evidence in ACHD remains limited. Current guidelines, extrapolated from non-congenital populations, may not fully address the anatomical and electrophysiological complexities in ACHD.
This retrospective cohort study aims to investigate the real-world efficacy and safety of CRT in adult patients with congenital heart disease (ACHD). The study includes consecutive ACHD patients who underwent either de novo CRT implantation or upgrade procedures, starting from January 2014.
The primary objectives are to evaluate changes in QRS duration, systemic ventricular function, and New York Heart Association (NYHA) functional class. The study aims to further examine the impact of CRT in specific ACHD subgroups, including patients with systemic right ventricles (vs. systemic left ventricles), those with non-left bundle branch block (non-LBBB) morphology (vs. LBBB), and those with upgrade procedures (vs. de novo implants).
Data collection is based on retrospective review of electronic health records, including patient demographics, clinical characteristics, device-related procedural details, and follow-up data. Outcomes are assessed using standardized echocardiographic and electrocardiographic measurements, alongside clinical evaluations.
The study aims to provide comprehensive real-world insights into the efficacy and safety of CRT in the diverse ACHD population and to identify predictors of favorable response, ultimately supporting more individualized decision-making in this complex patient group.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cardiac resynchronization therapy pacemaker or defibrillator with a transvenous or epicardial systemic ventricle lead
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Evaluation of the longitudinal effect of CRT on the duration (in ms) of the QRS interval on surface ECG
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
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)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Evaluation of the longitudinal effect of CRT on the NYHA functional classification (i.e., Class I, II, III, IV)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Death from any cause during the study period
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
At least one overnight stay with cardiac decompensation as the primary reason for hospitalization
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
At least one overnight stay due to any primary cardiovascular reason, excluding heart failure
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
An unplanned medical contact requiring decongestion, but no overnight stay in the hospital
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
An unplanned medical contact due to any primary cardiovascular reason, excluding heart failure and without overnight stay in the hospital
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Enlisting for left ventricular assist device (LVAD) implantation during the study period
Time frame: One year after implantation
Enlisting for heart transplantation (HTX) during the study period.
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Any complications occurring during or immediately after the procedure, including but not limited to pneumothorax, infection, bleeding, lead dislodgement, and arrhythmic events.
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Evaluation of the longitudinal change of the minimum pacing threshold required for consistent ventricular capture, measured in volts (V) at a specific pulse width (ms)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Evaluation of the longitudinal change of the systemic ventricular lead impedance, measured in ohms (Ω), reflecting the integrity of the pacing system and lead-tissue interface.
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Evaluation of the longitudinal change of the R-wave amplitude of the systemic ventricular lead, measured in millivolts (mV), indicating the ability of the system to correctly sense the ventricular depolarization
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Incidence of (in)appropriate ICD therapies, including shock or antitachycardia pacing
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Evaluation of the longitudinal change in the use of guideline-directed medical therapy (GDMT) for heart failure, including RAAS inhibitors (ACEi/ARB/ARNI), mineralocorticoid receptor antagonists (MRA), beta-blockers (BB), diuretics, and SGLT2 inhibitors (SGLT2i).
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Evaluation of the longitudinal effect of CRT on weight (kg)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Evaluation of the longitudinal effect of CRT on systolic blood pressure (mmHg)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Evaluation of the longitudinal effect of CRT on diastolic blood pressure (mmHg)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Evaluation of the longitudinal effect of CRT on heart rate (beats per minute)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Evaluation of the longitudinal effect of CRT on serum sodium (mmol/L)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Evaluation of the longitudinal effect of CRT on serum creatinine (μmol/L)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Evaluation of the longitudinal effect of CRT on estimated glomerular filtration rate (eGFR, ml/min/1.73m2)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Evaluation of the longitudinal effect of CRT on serum NT-proBNP (ng/L)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Evaluation of the longitudinal effect of CRT on serum high-sensitivity troponin T concentrations (ng/L)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Evaluation of the longitudinal effect of CRT on the echocardiographic functional classification of the subpulmonary ventricle (i.e., normal, mildly reduced, moderately reduced, severely reduced)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Evaluation of the longitudinal effect of CRT on the regurgitant grade of the systemic atrioventricular valve, classified as grade I, II, III, or IV.
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Evaluation of the longitudinal effect of CRT on the regurgitant grade of the pulmonary atrioventricular valve, classified as grade I, II, III, or IV.
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Evaluation of the longitudinal effect of CRT on systolic pulmonary artery pressure (sPAP), estimated by echocardiography.
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Evaluation of the longitudinal effect of CRT on inferior vena cava diameter and its collapsibility during respiration, as assessed by echocardiography.
Contact information is provided by the study sponsor or research team.
Leiden University Medical Center
Other
Acronym: RECORD-CHD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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