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

Last updated: October 12, 2023
Sponsor: University Hospital, Rouen
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Conduction system pacing

Clinical Study ID

NCT06088927
2020/0417/OB
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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. 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).

Eligibility Criteria

Inclusion

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 giveinformed consent

Exclusion

Exclusion Criteria:

  • Patient under guardianship, trusteeship, or legal protection.
  • Pregnant woman (positive urine pregnancy test) or breastfeeding or lack of proveneffective contraception (according to the WHO definition) or menopausal withoutconfirmed diagnosis (non-medically induced amenorrhea for at least 12 months beforethe inclusion visit).

Study Design

Total Participants: 2500
Treatment Group(s): 1
Primary Treatment: Conduction system pacing
Phase:
Study Start date:
March 01, 2023
Estimated Completion Date:
March 31, 2028

Connect with a study center

  • CHU Caen

    Caen,
    France

    Active - Recruiting

  • CHI Elbeuf

    Elbeuf,
    France

    Active - Recruiting

  • Groupe Hospitalier La Rochelle Ré-Aunis

    La Rochelle,
    France

    Active - Recruiting

  • CH Le Havre

    Le Havre,
    France

    Active - Recruiting

  • CHU Lille

    Lille,
    France

    Active - Recruiting

  • Hôpital Saint Philibert

    Lomme,
    France

    Active - Recruiting

  • CHU Rennes

    Rennes,
    France

    Active - Recruiting

  • Clinique Saint Hilaire

    Rouen,
    France

    Active - Recruiting

  • Rouen University Hospital

    Rouen, 76 031
    France

    Active - Recruiting

  • CHU Sud Réunion

    Saint-Pierre,
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.