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NCT Number: NCT06088927

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

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).

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Key information

Conditions

Conduction System Pacing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Caen, Caen, France

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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).

Treatment and study plan

conduction system pacing

Device

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

Primary outcomes

  1. Freedom from major adverse events

    Time frame: 24 months

    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

Secondary outcomes

  1. LVEF (%)

    Time frame: 24 months

  2. AF incidence

    Time frame: 24 months

  3. Heart Failure Hospitalization Incidence

    Time frame: 24 months

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

    Time frame: 24 months

  5. Paced QRS width

    Time frame: 24 months

  6. Interventricular dyssynchrony parameters

    Time frame: pre-discharged

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

  7. Intraventricular dyssynchrony parameters

    Time frame: pre-discharged

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

Study contacts

Contact information is provided by the study sponsor or research team.

Corentin Chaumont, MD

CONTACT

[email protected]

+ 33637182032

Frederic Anselme, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: STIMU'HIS

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Oct 18, 2023
Registry last updated
Oct 18, 2023

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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