Clinical trial NCT06088927: Long-term Outcomes of Conduction System Pacing: a National Multicenter Observational Study - NORMAND'HIS / STIMU'HIS
Official title: Long-term Outcomes of Conduction System Pacing: a National Multicenter Observational Study - NORMAND'HIS / STIMU'HIS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Conduction System Pacing
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients referred for conduction system pacing

Brief 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 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).

Primary outcomes:
measure: Freedom from major adverse events
timeFrame: 24 months
Secondary outcomes:
measure: LVEF (%)
timeFrame: 24 months
measure: AF incidence
timeFrame: 24 months
measure: Heart Failure Hospitalization Incidence
timeFrame: 24 months
measure: CSP Threshold during pacemaker check (Volt @ ms)
timeFrame: 24 months
measure: Paced QRS width
timeFrame: 24 months
measure: Interventricular dyssynchrony parameters
timeFrame: pre-discharged
measure: Intraventricular dyssynchrony parameters
timeFrame: pre-discharged
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen
city: Elbeuf
country: France
facility: CHI Elbeuf
city: La Rochelle
country: France
facility: Groupe Hospitalier La Rochelle Ré-Aunis
city: Le Havre
country: France
facility: CH Le Havre
city: Lille
country: France
facility: CHU Lille
city: Lomme
country: France
facility: Hôpital Saint Philibert
city: Rennes
country: France
facility: CHU Rennes
city: Rouen
country: France
facility: Rouen University Hospital
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Saint-Pierre
country: France
facility: CHU Sud Réunion
Study officials:
References: