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

Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: A Cross-Over Trial

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

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.

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.