Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT
NCT ID: NCT05524324
Last Updated: 2024-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2022-11-15
2026-05-15
Brief Summary
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Detailed Description
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Double blind randomized cross-over trial. 40 patients will be enroled. Their follow-up will be 6 months.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Victor WADLMANN
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Fabien LABOMBARDA
Role: primary
Sébastien HASCOET
Role: primary
Ali HOUEIJEH
Role: primary
Francis BESSIERE
Role: primary
Rita KOUTBI
Role: primary
Jean Luc PASQUIE
Role: primary
Jean Baptiste GOURRAUD
Role: primary
Guillaume DUTHOIT
Role: primary
Frédéric ANSLEME
Role: primary
Pierre MONDOLY
Role: primary
Nicolas COMBES
Role: primary
Bertrand PIERRE
Role: primary
Other Identifiers
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APHP211040
Identifier Type: -
Identifier Source: org_study_id
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