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
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