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

Last updated: July 10, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congenital Heart Disease

Heart Failure

Chest Pain

Treatment

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

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

Clinical Study ID

NCT05524324
APHP211040
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 QRSduration ≥ 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

Exclusion Criteria:

  • Pregnancy or breastfeeding

  • Women of childbearing potential who do not have a negative pregnancy test and do notuse one of the following methods of birth control: hormonal contraception orintrauterine device or bilateral tubal occlusion

  • Patient benefiting from a measure of legal protection (guardianship, curatorship,under judicial safeguard, activated future protection mandate and familyauthorization),

  • 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 6months,

  • 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 theexclusion period at the end of a previous study.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing)
Phase:
Study Start date:
November 15, 2022
Estimated Completion Date:
May 15, 2026

Study 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.

Connect with a study center

  • CHU de Caen

    Caen,
    France

    Active - Recruiting

  • Hôpital Marie-Lannelongue

    Le Plessis-Robinson,
    France

    Active - Recruiting

  • CHU de Lille

    Lille,
    France

    Site Not Available

  • Hôpital Louis Pradel

    Lyon,
    France

    Active - Recruiting

  • Hôpital La Timone

    Marseille,
    France

    Active - Recruiting

  • CHU de Montpellier

    Montpellier,
    France

    Active - Recruiting

  • CHU de Nantes

    Nantes,
    France

    Active - Recruiting

  • AP-HP, Pitié-Salpétrière

    Paris,
    France

    Active - Recruiting

  • Ap-Hp Hegp

    Paris, 75015
    France

    Active - Recruiting

  • CHU de Rouen

    Rouen,
    France

    Active - Recruiting

  • CHU de Toulouse

    Toulouse,
    France

    Site Not Available

  • Clinique Pasteur

    Toulouse,
    France

    Site Not Available

  • CHU de Tours

    Tours,
    France

    Active - Recruiting

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