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

NCT05524324 | Recruiting

• 1 other identifier: APHP211040
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 13

Brief Summary

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

Conditions

Congenital Heart Disease; Systemic Right Ventricle; Congenitally Corrected Transposition of the Great Arteries; Transposition of Great Vessels; Heart Failure Congenital

Keywords

cardiac resynchronization therapy; congenital heart disease; systemic right ventricle; heart failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

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.

Device: CRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing)

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.

Device: CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing)

Interventions

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.

CRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing)

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.

CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator

Study Sites (13)

CHU de Caen

Caen, France

RECRUITING

Hôpital Marie-Lannelongue

Le Plessis-Robinson, France

RECRUITING

CHU de Lille

Lille, France

NOT YET RECRUITING

Hôpital Louis Pradel

Lyon, France

RECRUITING

Hôpital La Timone

Marseille, France

RECRUITING

CHU de Montpellier

Montpellier, France

RECRUITING

CHU de Nantes

Nantes, France

RECRUITING

Ap-Hp Hegp

Paris, 75015, France

RECRUITING

AP-HP, Pitié-Salpétrière

Paris, France

RECRUITING

CHU de Rouen

Rouen, France

RECRUITING

CHU de Toulouse

Toulouse, France

NOT YET RECRUITING

Clinique Pasteur

Toulouse, France

NOT YET RECRUITING

CHU de Tours

Tours, France

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital; Congenitally Corrected Transposition of the Great Arteries; Transposition of Great Vessels; Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Victor WADLMANN

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karine Goude

CONTACT

+33 1 44 84 17 22; karine.goude@aphp.fr

Laura Le Mao

CONTACT

+33 1 56 09 54 97; laura.le-mao@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: September 1, 2022
• Study Start: November 15, 2022
• Primary Completion: February 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Two years after the last publication
• 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).

Locations

FR (13)