Clinical trial NCT04842851: Cardiac Resynchronization Therapy in Congenital Heart Diseases With Systemic Right Ventricle
Official title: Cardiac Resynchronization Therapy in Congenital Heart Diseases With Systemic Right Ventricle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Keywords: cardiac resynchronization therapy
congenital heart disease
systemic right ventricle
outcomes
Lead sponsor: Paris Cardiovascular Research Center (Inserm U970)
Sponsor class: OTHER_GOV
Collaborators: name: Marie Lannelongue Hospital, Le Plessis Robinson, France
name: Clinique Pasteur Toulouse
name: Groupe Hospitalier Pitie-Salpetriere
name: Hopital Louis Pradel
name: University Hospital, Montpellier
name: European Georges Pompidou Hospital
First posted: 2021-04-13
Enrollment: 85
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with congenital heart disease and CRT device. The group of patients with systemic right ventricle include patients with D-transposition of the great arteries (D-TGA) with atrial switch operation (Mustard or Senning surgery) and patients with congenitally-corrected transposition of the great arteries (cc-TGA) with SRV (excluding cc-TGA with systemic left ventricle post surgical repair, e.g., arterial switch procedure or Rastelli surgery).

Brief summary: This study aims to analyze outcomes of patients with systemic right ventricle (SRV) implanted with Cardiac Resynchronization Therapy (CRT) systems and to compare the impact of CRT in SRV patients with other congenital heart diseases (CHD).

Detailed description: Heart failure is henceforth the main cause of death in adult patients with congenital heart disease (CHD). The number of affected patients is expected to continue to grow exponentially due to the important increase and aging of this population.

In symptomatic patients despite optimal pharmacological therapy, Cardiac Resynchronization Therapy (CRT) offers a well-recognized therapeutic option in dilated and ischemic cardiomyopathies with severely impaired left ventricle ejection fraction and complete left bundle branch block. In patients with CHD, the level of evidence is much more limited. Underlying phenotypes are heterogeneous, including systemic right ventricles (SRVs), isolated sub-pulmonary right ventricle dysfunctions, single ventricles, and most of patients have a right bundle branch block. All these specificities question the extrapolation of data reported in patients with acquired cardiomyopathies. Despite the lack of evidence, CRT systems have been progressively used in CHD patients, also because alternative options are poor, mainly represented by cardiac transplantation, but grafts are rare and congenital patients frequently have contraindications.

A positive impact of CRT in CHD has first been suggested in small series where hemodynamic invasive parameters (e.g. dP/dt max) were improved and QRS narrowed by multisite pacing. A few subsequent studies then reported an improvement of ventricular functions and patient-reported functional subjective parameters (mainly NYHA classification). However, the number of patients included in most studies was limited and heterogeneous forms of CHD were often pooled when interpreting results. The studies evaluating CRT specifically in patients with SRV are very rare and demonstrated conflicting results. The largest study to date assessing specifically CRT in patients with SRV included 20 patients with congenitally corrected transposition of the great arteries (cc-TGA) and demonstrated an acute improvement in two-thirds of patients.

Although patients with SRV represent one of the main groups of CHD patients currently implanted with CRT, the paucity of specific data in this population has been highlighted as a major evidence gap and as a high-impact research question by the American Heart Association/American College of Cardiology guidelines committee.

Eligibility criteria: Inclusion Criteria:

* All patients with congenital heart disease and CRT device

Exclusion Criteria:

* Patient's refusal

Primary outcomes:
measure: Proportion of patients with response to CRT
timeFrame: 6-month, 12-month, 24-month
measure: Proportion of patients with response to CRT
timeFrame: 12-month
measure: Proportion of patients with response to CRT
timeFrame: 24-month
Secondary outcomes:
measure: Overall mortality
timeFrame: 5 and 10 years
measure: Overall mortality or heart transplantation
timeFrame: 5 and 10 years
measure: Complications associated with CRT
timeFrame: Acute (<30 days after procedure) and late (>30 days)
Other outcomes:
Locations:
Study officials:
affiliation: Georges Pompidou European Hospital, Paris, France
name: Victor Waldmann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: