NCT05401851

Brief Summary

Study of the ventricular activation patterns during left bundle area pacing and compare it with baseline activation during normal sinus rhythm in patients with and without baseline bundle branch conduction disorder.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

March 24, 2022

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2024

Completed
Last Updated

February 28, 2024

Status Verified

May 1, 2023

Enrollment Period

1.9 years

First QC Date

April 4, 2022

Last Update Submit

February 26, 2024

Conditions

BradyarrhythmiaPacemaker SyndromeBiventricular Cardiac Pacemaker Malfunction

Keywords

Left bundle area pacingPacemakerWide QRS

Outcome Measures

Primary Outcomes (2)

  • Epicardial map

    Activation patterns (visual inspection) on non-invasive 3D ECG mapping

    1 day

  • Epicardial map

    Activation time (ms) on non-invasive 3D ECG mapping

    1 day

Secondary Outcomes (2)

  • Echo parameters for resynchronization

    90 days

  • Echo parameters for resynchronization

    90 days

Study Arms (1)

Body surface mapping

OTHER

With the Insite Vest, activation of the epicardium will be performed.

Device: Left Bundel Area Pacing

Interventions

Left Bundel Area PacingDEVICE

RV Lead will be placed deep in the interventricular septum

Body surface mapping

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with a functional LBB-AP pacemaker

You may not qualify if:

  • Age \< 18 years
  • Previous cardiac surgery
  • Cardiomyopathy with documented ventricular scar
  • Patients with prior pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Carlo De Asmundis, MD, PhD

    UZ Brussels

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlo de Asmundis, MD, PhD

CONTACT

+32024763704HRMC@uzbrussel.be

Aurélie Dubois

CONTACT

+3224763254aurelie.dubois@uzbrussel.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2022

First Posted

June 2, 2022

Study Start

March 24, 2022

Primary Completion

February 21, 2024

Study Completion

October 21, 2024

Last Updated

February 28, 2024

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)