Real-World Data on the Effects of Cardiac Resynchronization Therapy in Adult Patients With Congenital Heart Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cardiac resynchronization therapy.
- Who it may be relevant to
- Registry conditions: Adult Congenital Heart Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Cardiac resynchronization therapy
Cardiac resynchronization therapy pacemaker or defibrillator with a transvenous or epicardial systemic ventricle lead
Primary outcome measures
- QRS duration [Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.]
- Systemic ventricle function class [Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.]
- NYHA functional class [Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.]
Secondary outcome measures (12)
- 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.]
Eligibility criteria
Inclusion criteria
- ACHD patients who underwent CRT implantation
Exclusion criteria
- Less than 18 years old on the moment of CRT implantation
- Patient objection to the use of retrospective data
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Leiden University Medical Center (LUMC) — Leiden
Identifiers
NCT: NCT06969924 · 2023-035