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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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The main objective of RIGHT-CRT is to assess the impact/efficacy of CRT on functional capacity in ACHD patients with SRV.
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 patients and will become an option of choice in this population. If results are negatives, futile CRT implantation may be avoided in this population in particular considering potential adverse effects and CRT-related complications.
Double blind randomized cross-over trial. 40 patients will be enroled. Their follow-up will be 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing) | Other | 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. |
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| CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing) | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute walk test | The 6-minute walk test will be performed by a trained technician, indoors, along a long, flat, straight, enclosed corridor with a hard surface and a minimal length of 30 meters. The length of the corridor will be marked every 3 meters and the turnaround points will be marked with a cone. The starting line will be marked on the floor using brightly colored tape. Specific and standardized instructions will be transmitted to the patient. | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Peak oxygen uptake | VO2 max (ml/kg/min) during exercise test with standardized protocol, | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) |
| NYHA classification |
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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:
Affiliation to a french social security system (beneficiary or legal)
Informed and signed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor WADLMANN | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Caen | Caen | France | ||||
| Hôpital Marie-Lannelongue |
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Two years after the last publication
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
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Double blind randomized cross-over trial. Two cross-over periods of 3 months comparing biventricular pacing (CRT ON) vs. inactive pacing (ventricular back-up pacing or left ventricular pacing alone in patients requiring pacing, CRT OFF), each period in random order.
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| CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing) | Device | 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. |
|
NYHA classification (class I to IV)
| Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) |
| Right ventricular ejection fraction | Right ventricular ejection fraction assessed by echocardiography (%) | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) |
| Tricuspid valve regurgitation | Tricuspid valve regurgitation grade (I to IV) assessed by echocardiography | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) |
| QRS duration | QRS duration measured on electrocardiogram | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) |
| Quality of life of patients | Minnesota living with heart failure and SF36v2 questionnaires | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) |
| BNP | BNP level | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) |
| Heart failure | Number of hospitalizations for heart failure | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) |
| Diuretics | Dose of diuretics prescribed | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) |
| Premature cross-over phase termination | Number of patients with need for premature cross-over phase termination to restore previous pacing settings | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) |
| Ventricular arrhythmias | Number of non-sustained and sustained ventricular arrhythmias | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) |
| 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 | 75015 | 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 |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D000080041 | Congenitally Corrected Transposition of the Great Arteries |
| D014188 | Transposition of Great Vessels |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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