Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: A Cross-Over Trial
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The main objective of RIGHT-CRT is to assess the impact/efficacy of CRT on functional capacity in ACHD patients with SRV.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
CHU de Caen
RECRUITING
Caen
Hôpital Marie-Lannelongue
RECRUITING
Le Plessis-robinson
CHU de Lille
NOT_YET_RECRUITING
Lille
Hôpital Louis Pradel
RECRUITING
Lyon
Hôpital La Timone
RECRUITING
Marseille
CHU de Montpellier
RECRUITING
Montpellier
CHU de Nantes
RECRUITING
Nantes
Ap-Hp Hegp
RECRUITING
Paris
AP-HP, Pitié-Salpétrière
RECRUITING
Paris
CHU de Rouen
RECRUITING
Rouen
CHU de Toulouse
NOT_YET_RECRUITING
Toulouse
Clinique Pasteur
NOT_YET_RECRUITING
Toulouse
CHU de Tours
RECRUITING
Tours
Contact Information
Primary
Karine Goude
karine.goude@aphp.fr
+33 1 44 84 17 22
Backup
Laura Le Mao
laura.le-mao@aphp.fr
+33 1 56 09 54 97
Time Frame
Start Date: 2022-11-15
Estimated Completion Date: 2026-05-15
Participants
Target number of participants: 40
Treatments
Other: CRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing)
Patients with heart failure and SRV and who have a dispositif CRT will be screened for eligibility. If they are eligible and accept to participate (signed informed consent), the order of activation or inactivation of the CRT will be assigned by randomization.Patients randomized into this arm will start the study in CRT ON then CRT OFF mode.
Other: CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing)
Patients with heart failure and SRV and who have a dispositif CRT will be screened for eligibility. If they are eligible and accept to participate (signed informed consent), the order of activation or inactivation of the CRT will be assigned by randomization.Patients randomized into this arm will start the study in CRT OFF then CRT ON mode.
Related Therapeutic Areas
Sponsors
Collaborators: Ministry of Health, France
Leads: Assistance Publique - Hôpitaux de Paris