Cardiac Resynchronization Therapy in Congenital Heart Diseases With Systemic Right Ventricle

Congenital Heart Disease Clinical Trial

Official title:

Cardiac Resynchronization Therapy in Congenital Heart Diseases With Systemic Right Ventricle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04842851
• Other study ID #: 2219047
• Status: Completed
• Start date: January 1, 2004
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2021
• Source: Paris Cardiovascular Research Center (Inserm U970)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients with congenital heart disease and CRT device

Exclusion Criteria:

• Patient's refusal

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Device:
• cardiac resynchronization therapy
Cardiac resynchronization therapy in patients with systemic right ventricle

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Paris Cardiovascular Research Center (Inserm U970)	Clinique Pasteur Toulouse, European Georges Pompidou Hospital, Groupe Hospitalier Pitie-Salpetriere, Hopital Louis Pradel, Marie Lannelongue Hospital, Le Plessis Robinson, France, University Hospital, Montpellier

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with response to CRT	Proportion of patients with improvement of NYHA classification by at least one grade or improvement of systemic ventricular ejection fraction by at least 10%	6-month, 12-month, 24-month
Primary	Proportion of patients with response to CRT	Proportion of patients with improvement of NYHA classification by at least one grade or improvement of systemic ventricular ejection fraction by at least 10%	12-month
Primary	Proportion of patients with response to CRT	Proportion of patients with improvement of NYHA classification by at least one grade or improvement of systemic ventricular ejection fraction by at least 10%	24-month
Secondary	Overall mortality	All cause mortality	5 and 10 years
Secondary	Overall mortality or heart transplantation	All cause mortality or heart transplantation	5 and 10 years
Secondary	Complications associated with CRT		Acute (<30 days after procedure) and late (>30 days)