Adult Congenital Heart DiseaseRECORD-CHDNCT06969924
Real-World Data on the Effects of Cardiac Resynchronization Therapy in Adult Patients With Congenital Heart Disease
An observational study of Adult Congenital Heart Disease, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Congenital Heart Disease
- What is being tested?
- Cardiac resynchronization therapy
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2014to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult congenital heart disease patients who received cardiac resynchronization therapy.
Who may be able to join
- ACHD patients who underwent CRT implantation
Who cannot join
- Less than 18 years old on the moment of CRT implantation
- Patient objection to the use of retrospective data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center (LUMC)
Leiden, South Holland, 2333ZA
Anastasia D. Egorova, MD, PhD, +31 71 5262020, a.egorova@lumc.nl
Bert A.C. Zwaenepoel, MD
About this study
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.
Read the detailed description
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.
- Conditions
- Adult Congenital Heart Disease
- Being tested
- Cardiac resynchronization therapy
- Keywords
- Adult congenital heart disease, Cardiac resynchronization therapy, ACHD, CRT, Heart failure, HF
- Medical subject headings
- Heart Defects, Congenital, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac resynchronization therapyDevice
Cardiac resynchronization therapy pacemaker or defibrillator with a transvenous or epicardial systemic ventricle lead
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Cardiac resynchronization therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
QRS duration
Evaluation of the longitudinal effect of CRT on the duration (in ms) of the QRS interval on surface ECG
Measured: 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)
Measured: 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)
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Secondary outcomes (27)
Clinical - Mortality
Death from any cause during the study period
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical - Heart failure hospitalization
At least one overnight stay with cardiac decompensation as the primary reason for hospitalization
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Jan 2014
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anastasia D. Egorova, MD, PhD, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969924
- Sponsor's protocol ID
- 2023-035
- Acronym
- RECORD-CHD
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Data on the Effects of Cardiac Resynchronization Therapy in Adult Patients With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT06969924
- Acronym / sponsor ID
- RECORD-CHD / 2023-035
- Conditions
- Adult Congenital Heart Disease
- Keywords
- Adult congenital heart disease, Cardiac resynchronization therapy, ACHD, CRT, Heart failure, HF
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACHD patients with CRT | – | Device: Cardiac resynchronization therapyAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult congenital heart disease patients who received cardiac resynchronization therapy.
Key inclusion criteria (1 listed)
- ACHD patients who underwent CRT implantation
Key exclusion criteria (2 listed)
- Less than 18 years old on the moment of CRT implantation
- Patient objection to the use of retrospective data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac resynchronization therapyCardiac resynchronization therapy pacemaker or defibrillator with a transvenous or epicardial systemic ventricle lead | Device | ACHD patients with CRT |
Primary outcome
QRS duration
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
Systemic ventricle function class
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)
NYHA functional class
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)
27 secondary outcomes
Clinical - Mortality
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical - Heart failure hospitalization
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical - CV hospitalization other than HF
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical - Urgent heart failure visit
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical - Urgent CV visit other than HF
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical - Enlisting for LVAD
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical - Enlisting for HTX
Time frame: One year after implantation
Clinical - Periprocedurel complications
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
CIED-related - Threshold systemic ventricular lead
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
CIED-related - Impedance systemic ventricular lead
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
CIED-related - R-wave sensing systemic ventricular lead
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
CIED-related - ICD therapy
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Medication - GDMT use
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical parameter - weight
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical parameter - systolic blood pressure
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical parameter - diastolic blood pressure
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical parameter - heart rate
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameter - sodium
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameter - creatinine
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameter - eGFR
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameter - NT-proBNP
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameter - hs-TnT
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Echocardiographic parameter - subpulmonary ventricle function class
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Echocardiographic parameter - SAVV regurgitant grade
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Echocardiographic parameter - PAVV regurgitant grade
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Echocardiographic parameter - sPAP
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Echocardiographic parameter - IVC diameter
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Congenital Heart Disease, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anastasia D. Egorova, MD, PhD (+31 71 5262020, a.egorova@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QRS duration (time frame: From enrollment through study completion, with an average follow-up duration of 1 year.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.