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

Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: A Cross-Over Trial

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

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karine Goude; Phone Number: +33 1 44 84 17 22; Email: karine.goude@aphp.fr
• Study Contact Backup: Name: Laura LE MAO; Phone Number: +33 1 56 09 54 97; Email: laura.le-mao@aphp.fr

Study Locations

• France
  • Caen, France
    • Recruiting
    • CHU de Caen
    • Contact: Fabien Labombarda
  • Le Plessis-Robinson, France
    • Recruiting
    • Hôpital Marie-Lannelongue
    • Contact: Sébastien Hascoet
  • Lille, France
    • Not yet recruiting
    • CHU de Lille
    • Contact: Ali HOUEIJEH
  • Lyon, France
    • Recruiting
    • Hôpital Louis Pradel
    • Contact: Françis BESSIERE
  • Marseille, France
    • Recruiting
    • Hôpital La Timone
    • Contact: Rita KOUTBI
  • Montpellier, France
    • Recruiting
    • CHU de Montpellier
    • Contact: Jean Luc PASQUIE
  • Nantes, France
    • Recruiting
    • CHU de Nantes
    • Contact: Jean Baptiste GOURRAUD
  • Paris, France, 75015
    • Recruiting
    • Ap-Hp Hegp
    • Contact: Victor Waldmann; Email: victor.waldmann@aphp.fr
  • Paris, France
    • Recruiting
    • AP-HP, Pitié-Salpétrière
    • Contact: Guillaume DUTHOIT
  • Rouen, France
    • Recruiting
    • CHU de ROUEN
    • Contact: Frédéric ANSLEME
  • Toulouse, France
    • Not yet recruiting
    • Clinique Pasteur
    • Contact: Nicolas COMBES
  • Toulouse, France
    • Not yet recruiting
    • CHU de Toulouse
    • Contact: Pierre MONDOLY
  • Tours, France
    • Recruiting
    • CHU de Tours
    • Contact: Bertrand PIERRE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Victor WADLMANN, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Estimated): February 15, 2026
• Study Completion (Estimated): May 15, 2026

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: cardiac resynchronization therapy; heart failure; congenital heart disease; systemic right ventricle
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Failure; Heart Diseases; Heart Defects, Congenital; Transposition of Great Vessels; Congenitally Corrected Transposition of the Great Arteries; Situs Inversus
• Other Study ID Numbers: APHP211040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
• IPD Sharing Time Frame: Two years after the last publication
• IPD Sharing Access Criteria: 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No