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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Rouen

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 population

All patients referred for conduction system pacing

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Conduction system pacing

    Device

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

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

Time frame
24 months

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

Other outcomes

Sponsors and contacts

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