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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
France
CHU Caen
RECRUITING
Caen
CHI Elbeuf
RECRUITING
Elbeuf
Groupe Hospitalier La Rochelle Ré-Aunis
RECRUITING
La Rochelle
CH Le Havre
RECRUITING
Le Havre
CHU Lille
RECRUITING
Lille
Hôpital Saint Philibert
RECRUITING
Lomme
CHU Rennes
RECRUITING
Rennes
Clinique Saint Hilaire
RECRUITING
Rouen
Rouen University Hospital
RECRUITING
Rouen
CHU Sud Réunion
RECRUITING
Saint-pierre
Contact Information
Primary
Corentin Chaumont, MD
corentin.chaumont@chu-rouen.fr
+ 33637182032
Backup
Frederic Anselme, MD, PhD
frederic.anselme@chu-rouen.fr
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 2500
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Rouen

This content was sourced from clinicaltrials.gov