RecruitingNCT06088927

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


Sponsor

University Hospital, Rouen

Enrollment

2,500 participants

Start Date

Mar 1, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria2

  • 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).

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Interventions

DEVICEConduction system pacing

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


Locations(10)

CHU Caen

Caen, France

CHI Elbeuf

Elbeuf, France

Groupe Hospitalier La Rochelle Ré-Aunis

La Rochelle, France

CH Le Havre

Le Havre, France

CHU Lille

Lille, France

Hôpital Saint Philibert

Lomme, France

CHU Rennes

Rennes, France

Rouen University Hospital

Rouen, France

Clinique Saint Hilaire

Rouen, France

CHU Sud Réunion

Saint-Pierre, France

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NCT06088927


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