Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT

Not Applicable

Recruiting

• Conditions: Transposition of Great Vessels; Systemic Right Ventricle; Congenitally Corrected Transposition of the Great Arteries; Heart Failure Congenital; Congenital Heart Disease
• Interventions: Device: CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing); Device: CRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing)

• Registration Number: NCT05524324
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-07-12
• Study First Submitted QC: 2022-08-29
• Study First Posted: 2022-09-01
• Study Start: 2022-11-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-11
• Primary Completion: 2026-02-15
• Study Completion: 2026-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing)	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 ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing)	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.

Primary Outcome Measures

Name	Time	Method
6-minute walk test	Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)	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.

Secondary Outcome Measures

Name	Time	Method
NYHA classification	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 (class I to IV)
Peak oxygen uptake	Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)	VO2 max (ml/kg/min) during exercise test with standardized protocol,
Right ventricular ejection fraction	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 assessed by echocardiography (%)
Premature cross-over phase termination	Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)	Number of patients with need for premature cross-over phase termination to restore previous pacing settings
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)	Number of non-sustained and sustained ventricular arrhythmias
BNP	Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)	BNP level
QRS duration	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 measured on electrocardiogram
Quality of life of patients	Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)	Minnesota living with heart failure and SF36v2 questionnaires
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)	Number of hospitalizations for heart failure
Diuretics	Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)	Dose of diuretics prescribed
Tricuspid valve regurgitation	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 grade (I to IV) assessed by echocardiography

Trial Locations

Locations (13)

CHU de Caen; 🇫🇷 Caen, France

Hôpital Louis Pradel; 🇫🇷 Lyon, France

CHU de Lille; 🇫🇷 Lille, France

Hôpital Marie-Lannelongue; 🇫🇷 Le Plessis-Robinson, France

CHU de Montpellier; 🇫🇷 Montpellier, France

Ap-Hp Hegp; 🇫🇷 Paris, France

CHU de Nantes; 🇫🇷 Nantes, France

Hôpital La Timone; 🇫🇷 Marseille, France

AP-HP, Pitié-Salpétrière; 🇫🇷 Paris, France

CHU de Rouen; 🇫🇷 Rouen, France

Clinique Pasteur; 🇫🇷 Toulouse, France

CHU de Tours; 🇫🇷 Tours, France

CHU de Toulouse; 🇫🇷 Toulouse, France