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

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).

Study Overview

• Status: Recruiting
• Conditions: Conduction System Pacing
• Intervention / Treatment: Device: Conduction system pacing

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Corentin Chaumont, MD; Phone Number: + 33637182032; Email: corentin.chaumont@chu-rouen.fr
• Study Contact Backup: Name: Frederic Anselme, MD, PhD; Email: Frederic.Anselme@chu-rouen.fr

Study Locations

• France
  • Caen, France
    • Recruiting
    • CHU CAEN
    • Contact: Pierre OLLITRAULT, MD
  • Elbeuf, France
    • Recruiting
    • CHI Elbeuf
    • Contact: Fabian Tournevache, MD
  • La Rochelle, France
    • Recruiting
    • Groupe Hospitalier La Rochelle Ré-Aunis
    • Contact: Antoine MILHEM, MD
  • Le Havre, France
    • Recruiting
    • CH Le Havre
    • Contact: Nathanaël Auquier, MD
  • Lille, France
    • Recruiting
    • Chu Lille
    • Contact: Christelle MARQUIE, MD
  • Lomme, France
    • Recruiting
    • Hôpital Saint Philibert
    • Contact: Guillaume VIART, MD
  • Rennes, France
    • Recruiting
    • CHU Rennes
    • Contact: Vincent GALAND, MD
  • Rouen, France
    • Recruiting
    • Clinique Saint Hilaire
    • Contact: Adrian Mirolo, MD
  • Rouen, France, 76 031
    • Recruiting
    • Rouen University Hospital
    • Contact: Corentin Chaumont, MD
  • Saint-Pierre, France
    • Recruiting
    • CHU Sud Réunion
    • Contact: Gael Clerici, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All patients referred for conduction system pacing

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2020/0417/OB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No