Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACHD patients with CRT | All participants included in the registry have to have a congenital heart defect, be ≥ 18 years old and have to have a CRT pacemaker or defibrillator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac resynchronization therapy | Device | Cardiac resynchronization therapy pacemaker or defibrillator with a transvenous or epicardial systemic ventricle lead |
|
| Measure | Description | Time Frame |
|---|---|---|
| QRS duration | Evaluation of the longitudinal effect of CRT on the duration (in ms) of the QRS interval on surface ECG | From enrollment through study completion, with an average follow-up duration of 1 year. |
| 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) | From enrollment through study completion, with an average follow-up duration of 1 year. |
| NYHA functional class | Evaluation of the longitudinal effect of CRT on the NYHA functional classification (i.e., Class I, II, III, IV) | From enrollment through study completion, with an average follow-up duration of 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical - Mortality | Death from any cause during the study period | From enrollment through study completion, with an average follow-up duration of 1 year. |
| Clinical - Heart failure hospitalization |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All adult congenital heart disease patients who received cardiac resynchronization therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anastasia D. Egorova, MD, PhD | Contact | +31 71 5262020 | a.egorova@lumc.nl |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center (LUMC) | Recruiting | Leiden | South Holland | 2333ZA | Netherlands |
Not provided
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
At least one overnight stay with cardiac decompensation as the primary reason for hospitalization
| From enrollment through study completion, with an average follow-up duration of 1 year. |
| Clinical - CV hospitalization other than HF | At least one overnight stay due to any primary cardiovascular reason, excluding heart failure | From enrollment through study completion, with an average follow-up duration of 1 year. |
| Clinical - Urgent heart failure visit | An unplanned medical contact requiring decongestion, but no overnight stay in the hospital | From enrollment through study completion, with an average follow-up duration of 1 year. |
| Clinical - Urgent CV visit other than HF | An unplanned medical contact due to any primary cardiovascular reason, excluding heart failure and without overnight stay in the hospital | From enrollment through study completion, with an average follow-up duration of 1 year. |
| Clinical - Enlisting for LVAD | Enlisting for left ventricular assist device (LVAD) implantation during the study period | From enrollment through study completion, with an average follow-up duration of 1 year. |
| Clinical - Enlisting for HTX | Enlisting for heart transplantation (HTX) during the study period. | One year after implantation |
| Clinical - Periprocedurel complications | Any complications occurring during or immediately after the procedure, including but not limited to pneumothorax, infection, bleeding, lead dislodgement, and arrhythmic events. | From enrollment through study completion, with an average follow-up duration of 1 year. |
| CIED-related - Threshold systemic ventricular lead | 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) | From enrollment through study completion, with an average follow-up duration of 1 year. |
| CIED-related - Impedance systemic ventricular lead | 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. | From enrollment through study completion, with an average follow-up duration of 1 year. |
| CIED-related - R-wave sensing systemic ventricular lead | 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 | From enrollment through study completion, with an average follow-up duration of 1 year. |
| CIED-related - ICD therapy | Incidence of (in)appropriate ICD therapies, including shock or antitachycardia pacing | From enrollment through study completion, with an average follow-up duration of 1 year. |
| Medication - GDMT use | 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). | From enrollment through study completion, with an average follow-up duration of 1 year. |
| Clinical parameter - weight | Evaluation of the longitudinal effect of CRT on weight (kg) | From enrollment through study completion, with an average follow-up duration of 1 year. |
| Clinical parameter - systolic blood pressure | Evaluation of the longitudinal effect of CRT on systolic blood pressure (mmHg) | From enrollment through study completion, with an average follow-up duration of 1 year. |
| Clinical parameter - diastolic blood pressure | Evaluation of the longitudinal effect of CRT on diastolic blood pressure (mmHg) | From enrollment through study completion, with an average follow-up duration of 1 year. |
| Clinical parameter - heart rate | Evaluation of the longitudinal effect of CRT on heart rate (beats per minute) | From enrollment through study completion, with an average follow-up duration of 1 year. |
| Laboratory parameter - sodium | Evaluation of the longitudinal effect of CRT on serum sodium (mmol/L) | From enrollment through study completion, with an average follow-up duration of 1 year. |
| Laboratory parameter - creatinine | Evaluation of the longitudinal effect of CRT on serum creatinine (μmol/L) | From enrollment through study completion, with an average follow-up duration of 1 year. |
| Laboratory parameter - eGFR | Evaluation of the longitudinal effect of CRT on estimated glomerular filtration rate (eGFR, ml/min/1.73m2) | From enrollment through study completion, with an average follow-up duration of 1 year. |
| Laboratory parameter - NT-proBNP | Evaluation of the longitudinal effect of CRT on serum NT-proBNP (ng/L) | From enrollment through study completion, with an average follow-up duration of 1 year. |
| Laboratory parameter - hs-TnT | Evaluation of the longitudinal effect of CRT on serum high-sensitivity troponin T concentrations (ng/L) | From enrollment through study completion, with an average follow-up duration of 1 year. |
| Echocardiographic parameter - subpulmonary ventricle function class | 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) | From enrollment through study completion, with an average follow-up duration of 1 year. |
| Echocardiographic parameter - SAVV regurgitant grade | Evaluation of the longitudinal effect of CRT on the regurgitant grade of the systemic atrioventricular valve, classified as grade I, II, III, or IV. | From enrollment through study completion, with an average follow-up duration of 1 year. |
| Echocardiographic parameter - PAVV regurgitant grade | Evaluation of the longitudinal effect of CRT on the regurgitant grade of the pulmonary atrioventricular valve, classified as grade I, II, III, or IV. | From enrollment through study completion, with an average follow-up duration of 1 year. |
| Echocardiographic parameter - sPAP | Evaluation of the longitudinal effect of CRT on systolic pulmonary artery pressure (sPAP), estimated by echocardiography. | From enrollment through study completion, with an average follow-up duration of 1 year. |
| Echocardiographic parameter - IVC diameter | Evaluation of the longitudinal effect of CRT on inferior vena cava diameter and its collapsibility during respiration, as assessed by echocardiography. | From enrollment through study completion, with an average follow-up duration of 1 year. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |