Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Heart Failure Congenital

Congenitally Corrected Transposition of the Great Arteries

Systemic Right Ventricle

Transposition of Great Vessels

Congenital Heart Disease

Treatments

Device: CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing)

Device: CRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing)

Study type

Interventional

Funder types

Other

Identifiers

NCT05524324

APHP211040

Details and patient eligibility

About

The main objective of RIGHT-CRT is to assess the impact/efficacy of CRT on functional capacity in ACHD patients with SRV.

Full description

This study will be the first to bring evidence on CRT efficacy in ACHD patients with heart failure and SRV. If results are positives, CRT may improve functional capacities and quality of life of patients and will become an option of choice in this population. If results are negatives, futile CRT implantation may be avoided in this population in particular considering potential adverse effects and CRT-related complications.

Double blind randomized cross-over trial. 40 patients will be enroled. Their follow-up will be 6 months.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

systemic right ventricle (SRV),
CRT-P or CRT-D device implanted for at least 1 month,
Age ≥18 years old,
One of the two following CRT indications:
- NYHA II-IV, right ventricular ejection fraction ≤ 35% and spontaneous QRS duration ≥ 150 ms Or
- NYHAI-IV, atrioventricular conduction disorders with ventricular pacing > 40% (regardless right ventricular ejection fraction).
Affiliation to a french social security system (beneficiary or legal)
Informed and signed consent

Exclusion criteria

Pregnancy or breastfeeding
Women of childbearing potential who do not have a negative pregnancy test and do not use one of the following methods of birth control: hormonal contraception or intrauterine device or bilateral tubal occlusion
Patient benefiting from a measure of legal protection (guardianship, curatorship, under judicial safeguard, activated future protection mandate and family authorization),
Cardiac surgery during the last 3 months or planned during the next 6 months,
Percutaneous structural cardiac intervention planned during the next 6 months,
Persistent atrial arrhythmia with catheter ablation planned during the next 6 months,
Acute congestive heart failure,
Dysfunction of at least one CRT device lead that compromise biventricular pacing,
Patient on AME
Current participation in another interventional clinical study or being in the exclusion period at the end of a previous study.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

40 participants in 2 patient groups

CRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing)

Other group

Description:

Patients with heart failure and SRV and who have a dispositif CRT will be screened for eligibility. If they are eligible and accept to participate (signed informed consent), the order of activation or inactivation of the CRT will be assigned by randomization.Patients randomized into this arm will start the study in "CRT ON" then "CRT OFF" mode.

Treatment:

Device: CRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing)

CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing)

Other group

Description:

Treatment:

Device: CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing)