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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

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

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.

DEVICE

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

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)

CHU de Caen
Caen, France
Hôpital Marie-Lannelongue
Le Plessis-Robinson, France
CHU de Lille
Lille, France
Hôpital Louis Pradel
Lyon, France
Hôpital La Timone
Marseille, France
CHU de Montpellier
Montpellier, France
CHU de Nantes
Nantes, France
Ap-Hp Hegp
Paris, France
AP-HP, Pitié-Salpétrière
Paris, France
CHU de Rouen
Rouen, France
CHU de Toulouse
Toulouse, France
Clinique Pasteur
Toulouse, France
CHU de Tours
Tours, France