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
Assistance Publique - Hôpitaux de Paris
40 participants
Nov 15, 2022
INTERVENTIONAL
Conditions
Summary
The main objective of RIGHT-CRT is to assess the impact/efficacy of CRT on functional capacity in ACHD patients with SRV.
Eligibility
Inclusion Criteria8
- 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 Criteria10
- 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.
Interventions
Patients randomized to the CRT ON / CRT OFF arm will undergo a first intervention to activate their device and then a second intervention for 3 months to inactivate their device.
Patients randomized to the CRT OFF / CRT ON arm will undergo a first intervention to inactivate their device and then a second intervention for 3 months to activate their device.
Locations(13)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05524324