Status:
RECRUITING
Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Congenital Heart Disease
Systemic Right Ventricle
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main objective of RIGHT-CRT is to assess the impact/efficacy of CRT on functional capacity in ACHD patients with SRV.
Detailed 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 patie...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05524324
Start Date
November 15 2022
End Date
May 15 2026
Last Update
July 11 2024
Active Locations (13)
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1
CHU de Caen
Caen, France
2
Hôpital Marie-Lannelongue
Le Plessis-Robinson, France
3
CHU de Lille
Lille, France
4
Hôpital Louis Pradel
Lyon, France