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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLeiden University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ACHD patients who underwent CRT implantation

Disqualifiers

Less than 18 years old on the moment of CRT implantation

Patient objection to the use of retrospective data

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Cardiac resynchronization therapy

    Device

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: ACHD patients with CRT1 intervention

Trial outcomes

Primary outcomes

1

QRS duration

Evaluation of the longitudinal effect of CRT on the duration (in ms) of the QRS interval on surface ECG

Time frame
From enrollment through study completion, with an average follow-up duration of 1 year.
2

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)

Time frame
From enrollment through study completion, with an average follow-up duration of 1 year.
3

NYHA functional class

Evaluation of the longitudinal effect of CRT on the NYHA functional classification (i.e., Class I, II, III, IV)

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

Secondary outcomes

1

Clinical - Mortality

Death from any cause during the study period

Time frame
From enrollment through study completion, with an average follow-up duration of 1 year.
2

Clinical - Heart failure hospitalization

At least one overnight stay with cardiac decompensation as the primary reason for hospitalization

Time frame
From enrollment through study completion, with an average follow-up duration of 1 year.
3

Clinical - CV hospitalization other than HF

At least one overnight stay due to any primary cardiovascular reason, excluding heart failure

Time frame
From enrollment through study completion, with an average follow-up duration of 1 year.
4

Clinical - Urgent heart failure visit

An unplanned medical contact requiring decongestion, but no overnight stay in the hospital

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

Other outcomes

Sponsors and contacts

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