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

NCT06969924 | Recruiting FDA Device

• 1 other identifier: 2023-035
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Congenital Heart Disease

Keywords

Adult congenital heart disease; Cardiac resynchronization therapy; ACHD; CRT; Heart failure; HF

Outcome Measures

Primary Outcomes (3)

• 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.

Secondary Outcomes (27)

• Clinical - Mortality

  From enrollment through study completion, with an average follow-up duration of 1 year.

• Clinical - Heart failure hospitalization

  From enrollment through study completion, with an average follow-up duration of 1 year.

• Clinical - CV hospitalization other than HF

  From enrollment through study completion, with an average follow-up duration of 1 year.

• Clinical - Urgent heart failure visit

  From enrollment through study completion, with an average follow-up duration of 1 year.

• Clinical - Urgent CV visit other than HF

  From enrollment through study completion, with an average follow-up duration of 1 year.

Study Arms (1)

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

Device: Cardiac resynchronization therapy

Interventions

Cardiac resynchronization therapy DEVICE

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

ACHD patients with CRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult congenital heart disease patients who received cardiac resynchronization therapy.

You may qualify if:

• ACHD patients who underwent CRT implantation

You may not qualify if:

• Less than 18 years old on the moment of CRT implantation
• Patient objection to the use of retrospective data

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center (LUMC)

Leiden, South Holland, 2333ZA, Netherlands

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital; Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Central Study Contacts

Anastasia D. Egorova, MD, PhD

CONTACT

+31 71 5262020; a.egorova@lumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 14, 2025
• Study Start: January 1, 2014
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 14, 2025

Record last verified: 2025-04

Locations

NL (1)