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Conduction System PacingSTIMU'HISNCT06088927

Long-term Outcomes of Conduction System Pacing: a National Multicenter Observational Study - NORMAND'HIS / STIMU'HIS

An observational study of Conduction System Pacing, run by University Hospital, Rouen at 10 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This prospective multicenter registry will evaluate the long-term electrical, echocardiographic, and clinical outcomes of conduction system pacing (CSP). There is currently limited data in the literature regarding the long-term results and benefits of CSP. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Conduction System Pacing
What is being tested?
Conduction system pacing
Type of treatment
Medical device
How many people
2,500 participants
Where
10 sitesFrance
Study dates
1 Mar 2023to 31 Mar 2028
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: All patients referred for conduction system pacing

Who may be able to join

  • Patient who had undergone conduction system pacing attempt
  • Age > 18 yo
  • Capacity to understand the nature of the study, legal ability and willingness to give informed consent

Who cannot join

  • Patient under guardianship, trusteeship, or legal protection.
  • Pregnant woman (positive urine pregnancy test) or breastfeeding or lack of proven effective contraception (according to the WHO definition) or menopausal without confirmed diagnosis (non-medically induced amenorrhea for at least 12 months before the inclusion visit).

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Corentin Chaumont, MD contact

+ 33637182032

corentin.chaumont@chu-rouen.fr

Frederic Anselme, MD, PhD contact

frederic.anselme@chu-rouen.fr

10 sites in 1 country

France10 sites, 10 recruiting

  • CHU Caen

    Caen

    Pierre Ollitrault, MD

    Recruiting

  • CHI Elbeuf

    Elbeuf

    Fabian Tournevache, MD

    Recruiting

  • Groupe Hospitalier La Rochelle Ré-Aunis

    La Rochelle

    Antoine Milhem, MD

    Recruiting

  • CH Le Havre

    Le Havre

    Nathanaël Auquier, MD

    Recruiting

  • CHU Lille

    Lille

    Christelle Marquié, MD

    Recruiting

  • Hôpital Saint Philibert

    Lomme

    Guillaume Viart, MD

    Recruiting

  • CHU Rennes

    Rennes

    Vincent Galand, MD

    Recruiting

  • Rouen University Hospital

    Rouen, 76 031

    Corentin Chaumont, MD

    Recruiting

  • Clinique Saint Hilaire

    Rouen

    Adrian Mirolo, MD

    Recruiting

  • CHU Sud Réunion

    Saint-Pierre

    Gaël Clérici, MD

    Recruiting

Other trials in France

About this study

This prospective multicenter registry will evaluate the long-term electrical, echocardiographic, and clinical outcomes of conduction system pacing (CSP). There is currently limited data in the literature regarding the long-term results and benefits of CSP. The long-term maintenance of conduction system (His bundle or Left Bundle Branch) capture and physiological ventricular activation is an essential prerequisite for the expected benefits of this technique.

There is currently no prospective study evaluating the preservation of CSP during long-term follow-up. The design of the present study will allow reliable evaluation of CSP maintenance at 2 years follow-up. The prospective collection of electrical data (pacing thresholds, impedance, R wave sensing) during pacemaker follow-up visits will confirm thresholds stability over the long term. The incidence of atrial fibrillation episodes will also be precisely evaluated and will provide new information. Although pathophysiological studies have demonstrated less impairment of left atrial function with conduction system pacing, there is currently no data on the incidence of atrial fibrillation in patients implanted with a CSP pacemaker.

Echocardiographic data will be prospectively collected in order to analyse the evolution of left ventricular ejection fraction (LVEF) after CSP. This systematic follow-up is rarely found in CSP studies, often retrospective, with significant missing echocardiographic data. The hypothesis is that patients benefiting from CSP will not develop the deleterious effects demonstrated with conventional right ventricular pacing, such as left ventricular dilation and LVEF impairment. Inter- and intraventricular asynchrony criteria will also be systematically evaluated during follow-up echocardiography.Finally, this prospective cohort will also systematically collect clinical follow-up data (hospitalizations for heart failure and NYHA stage).

Being tested
Conduction system pacing

What participants receive

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

  • Conduction system pacingDevice

    Conduction system pacing (His Bundle Pacing or Left Bundle Branch Area Pacing)

What is being measured

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

  1. Freedom from major adverse events

    Major adverse events are defined as follow :

    • Lead revision (including infection and pacing threshold increase)
    • Lead dislodgment
    • Loss of conduction system pacing (i.e. loss of His Bundle Pacing or Left Bundle Branch area pacing according to standard definitions)
    • Heart Failure Hospitalization
    • Upgrade to BiVentricular pacing
    • All cause mortality

    Measured: 24 months

Secondary outcomes (7)

  1. LVEF (%)

    Measured: 24 months

  2. AF incidence

    Measured: 24 months

  3. Heart Failure Hospitalization Incidence

    Measured: 24 months

  4. CSP Threshold during pacemaker check (Volt @ ms)

    Measured: 24 months

  5. Paced QRS width

    Measured: 24 months

  6. Interventricular dyssynchrony parameters

    Aortic pre-ejection time (ms) - Pulmonary pre-ejection time (ms) (echocardiography)

    Measured: pre-discharged

  7. Intraventricular dyssynchrony parameters

    Difference between the first and last left ventricular systolic peak using 2D speckle tracking (echocardiography)

    Measured: pre-discharged

Timeline

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

  1. First posted18 Oct 2023
  2. Study start1 Mar 2023
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,500 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06088927
Sponsor's protocol ID
2020/0417/OB
Acronym
STIMU'HIS
Status last verified
Mar 2023
First submitted
12 May 2023
Last updated
18 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Conduction System Pacing, run by University Hospital, Rouen at 10 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Corentin Chaumont, MD (+ 33637182032, corentin.chaumont@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from major adverse events (time frame: 24 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 NCT06088927.

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 18 Oct 2023.

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