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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Aug 29, 2022

Keywords

ClinConnect Summary

The RIGHT-CRT trial is studying how effective a treatment called Cardiac Resynchronization Therapy (CRT) is for adults with congenital heart disease who have a specific heart condition known as systemic right ventricle (SRV). This trial aims to determine if CRT can improve how well these patients function in their daily lives. Eligible participants are adults aged 18 and older who have had a CRT device implanted for at least one month and meet certain health criteria related to their heart function.

If you or a loved one is considering participating, you can expect to be closely monitored throughout the study. Participants will need to give informed consent, meaning they will be fully informed about the study and agree to take part. It's also important to note that there are specific conditions that would exclude someone from participating, such as being pregnant or having had recent heart surgery. This trial is currently recruiting participants, and it is a great opportunity for those looking to explore new treatment options for their condition.

Gender

ALL

Eligibility criteria

• 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.