NCT06088927

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Mar 2023Mar 2028

Study Start

First participant enrolled

March 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

October 18, 2023

Status Verified

March 1, 2023

Enrollment Period

5.1 years

First QC Date

May 12, 2023

Last Update Submit

October 12, 2023

Conditions

Conduction System Pacing

Outcome Measures

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

    24 months

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Interventions

Conduction system pacingDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients referred for conduction system pacing

You may qualify if:

  • 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

You may not qualify if:

  • Patient under guardianship, trusteeship, or legal protection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CHU Caen

Caen, France

RECRUITING

CHI Elbeuf

Elbeuf, France

RECRUITING

Groupe Hospitalier La Rochelle Ré-Aunis

La Rochelle, France

RECRUITING

CH Le Havre

Le Havre, France

RECRUITING

CHU Lille

Lille, France

RECRUITING

Hôpital Saint Philibert

Lomme, France

RECRUITING

CHU Rennes

Rennes, France

RECRUITING

Rouen University Hospital

Rouen, 76 031, France

RECRUITING

Clinique Saint Hilaire

Rouen, France

RECRUITING

CHU Sud Réunion

Saint-Pierre, France

RECRUITING

Central Study Contacts

Corentin Chaumont, MD

CONTACT

+ 33637182032corentin.chaumont@chu-rouen.fr

Frederic Anselme, MD, PhD

CONTACT

frederic.anselme@chu-rouen.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2023

First Posted

October 18, 2023

Study Start

March 1, 2023

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

October 18, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(10)