Evaluating cardiac resynchronization therapy effects in adults with congenital heart disease
Real-World Data on the Effects of Cardiac Resynchronization Therapy in Adult Patients With Congenital Heart Disease
This study is trying to see if cardiac resynchronization therapy can help adults with congenital heart disease feel better and improve their heart function.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Leiden, South Holland) |
| Trial ID | NCT06969924 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the real-world effects of cardiac resynchronization therapy (CRT) on adult patients with congenital heart disease (ACHD). It aims to assess whether CRT improves clinical outcomes such as QRS duration, ventricular function, and functional class in this unique population. The study involves a retrospective cohort of ACHD patients who received CRT from January 2014, analyzing data from electronic health records to identify factors associated with positive therapy responses. The findings will help clarify the efficacy and safety of CRT in ACHD, which is often overlooked in existing guidelines.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients with congenital heart disease who have undergone cardiac resynchronization therapy implantation.
Not a fit: Patients under 18 years old or those who object to the use of retrospective data will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into improving treatment outcomes for adults with congenital heart disease through CRT.
How similar studies have performed: While CRT is well-established in acquired heart failure, evidence in ACHD is limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leiden, South Holland
- Leiden University Medical Center (LUMC) — Leiden, South Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Anastasia D. Egorova, MD, PhD
- Email: a.egorova@lumc.nl
- Phone: +31 71 5262020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.