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Completed

NCT Number: NCT05524324

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

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

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Congenitally Corrected Transposition of the Great Arteries Heart Defects, Congenital Heart Diseases Heart Failure Heart Failure Congenital Systemic Right Ventricle Transposition of Great Vessels

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Caen, Caen, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. 6-minute walk test

    Time frame: 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 outcomes

  1. Peak oxygen uptake

    Time frame: 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,

  2. NYHA classification

    Time frame: 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)

  3. Right ventricular ejection fraction

    Time frame: 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 (%)

  4. Tricuspid valve regurgitation

    Time frame: 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

  5. QRS duration

    Time frame: 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

  6. Quality of life of patients

    Time frame: 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

  7. BNP

    Time frame: 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

  8. Heart failure

    Time frame: 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

  9. Diuretics

    Time frame: 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

  10. Premature cross-over phase termination

    Time frame: 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

  11. Ventricular arrhythmias

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: RIGHT-CRT

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 1, 2022
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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