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

Recruiting

• Conditions: Conduction System Pacing

• Registration Number: NCT06088927
• Lead Sponsor: University Hospital, Rouen

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study Start: 2023-03-01
• Study First Submitted: 2023-05-12
• Study First Submitted QC: 2023-10-12
• Last Update Submitted: 2023-10-12
• Study First Posted: 2023-10-18
• Last Update Posted: 2023-10-18
• Primary Completion: 2028-03-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from major adverse events	24 months	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

Secondary Outcome Measures

Name	Time	Method
AF incidence	24 months
Heart Failure Hospitalization Incidence	24 months
LVEF (%)	24 months
Paced QRS width	24 months
Interventricular dyssynchrony parameters	pre-discharged	Aortic pre-ejection time (ms) - Pulmonary pre-ejection time (ms) (echocardiography)
CSP Threshold during pacemaker check (Volt @ ms)	24 months
Intraventricular dyssynchrony parameters	pre-discharged	Difference between the first and last left ventricular systolic peak using 2D speckle tracking (echocardiography)

Trial Locations

Locations (10)

CHU Caen; 🇫🇷 Caen, France

CHI Elbeuf; 🇫🇷 Elbeuf, France

Rouen University Hospital; 🇫🇷 Rouen, France

Groupe Hospitalier La Rochelle Ré-Aunis; 🇫🇷 La Rochelle, France

CH Le Havre; 🇫🇷 Le Havre, France

Hôpital Saint Philibert; 🇫🇷 Lomme, France

CHU Lille; 🇫🇷 Lille, France

CHU Rennes; 🇫🇷 Rennes, France

Clinique Saint Hilaire; 🇫🇷 Rouen, France

CHU Sud Réunion; 🇫🇷 Saint-Pierre, France