Real-World Data on the Effects of Cardiac Resynchronization Therapy in Adult Patients With Congenital Heart Disease

NCT ID: NCT06969924

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2028-12-31

Brief 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 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.

Conditions

Adult Congenital Heart Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

Cardiac resynchronization therapy

Intervention Type: DEVICE

Cardiac resynchronization therapy pacemaker or defibrillator with a transvenous or epicardial systemic ventricle lead

Interventions

Cardiac resynchronization therapy

Cardiac resynchronization therapy pacemaker or defibrillator with a transvenous or epicardial systemic ventricle lead

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Anastasia D. Egorova, MD, PhD

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Leiden University Medical Center (LUMC)

Leiden, South Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Anastasia D. Egorova, MD, PhD

Role: CONTACT

a.egorova@lumc.nl

+31 71 5262020

Facility Contacts

Anastasia D. Egorova, MD, PhD

Role: primary

a.egorova@lumc.nl

+31 71 5262020

Other Identifiers

2023-035

Identifier Type: -

Identifier Source: org_study_id