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Congenital Heart DiseaseRIGHT-CRTNCT05524324

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

A study testing CRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing) and CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing) in people with Congenital Heart Disease and Systemic Right Ventricle, run by Assistance Publique - Hôpitaux de Paris at 13 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
CRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing) and CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
13 sitesFrance
Study dates
15 Nov 2022to 24 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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,
Show all 10Show fewer
  • 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.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

France13 sites

  • CHU de Caen

    Caen

  • Hôpital Marie-Lannelongue

    Le Plessis-Robinson

  • CHU de Lille

    Lille

  • Hôpital Louis Pradel

    Lyon

  • Hôpital La Timone

    Marseille

  • CHU de Montpellier

    Montpellier

  • CHU de Nantes

    Nantes

  • Ap-Hp Hegp

    Paris, 75015

  • AP-HP, Pitié-Salpétrière

    Paris

  • CHU de Rouen

    Rouen

  • CHU de Toulouse

    Toulouse

  • Clinique Pasteur

    Toulouse

  • CHU de Tours

    Tours

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
CRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing), CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing)
Keywords
cardiac resynchronization therapy, congenital heart disease, systemic right ventricle, heart failure
Medical subject headings
Heart Defects, Congenital, Congenitally Corrected Transposition of the Great Arteries, Transposition of Great Vessels, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05524324
Study groupRoleWhat they receive
CRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing)OtherPatients 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.
Receives: Device: CRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing)
CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing)OtherPatients 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.
Receives: Device: CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Peak oxygen uptake

    VO2 max (ml/kg/min) during exercise test with standardized protocol,

    Measured: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)

  2. NYHA classification

    NYHA classification (class I to IV)

    Measured: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)

  3. Right ventricular ejection fraction

    Right ventricular ejection fraction assessed by echocardiography (%)

    Measured: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)

  4. Tricuspid valve regurgitation

    Tricuspid valve regurgitation grade (I to IV) assessed by echocardiography

    Measured: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)

  5. QRS duration

    QRS duration measured on electrocardiogram

    Measured: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)

  6. Quality of life of patients

    Minnesota living with heart failure and SF36v2 questionnaires

    Measured: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)

  7. BNP

    BNP level

    Measured: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)

  8. Heart failure

    Number of hospitalizations for heart failure

    Measured: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)

  9. Diuretics

    Dose of diuretics prescribed

    Measured: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)

  10. Premature cross-over phase termination

    Number of patients with need for premature cross-over phase termination to restore previous pacing settings

    Measured: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)

  11. Ventricular arrhythmias

    Number of non-sustained and sustained ventricular arrhythmias

    Measured: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2022
  2. Study start15 Nov 2022
  3. Primary completion24 Apr 2026
  4. Study completion24 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05524324
Sponsor's protocol ID
APHP211040
Acronym
RIGHT-CRT
Status last verified
Jun 2026
First submitted
12 Jul 2022
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Questions about this trial

What is this clinical trial studying?

A study testing CRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing) and CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing) in people with Congenital Heart Disease and Systemic Right Ventricle, run by Assistance Publique - Hôpitaux de Paris at 13 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05524324.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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