Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution (LBBOT)

November 27, 2025 updated by: MicroPort CRM
To evaluate the capability to monitor LBB success criteria with the use of a Smart ECG system (ECG monitor, 12 leads ECG cable, ECG viewer software ) during a cardiac device implantation involving the placement of a pacing lead in interventricular septum area

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The clinical investigation aims to support physicians with a portable and easy to use solution to display ECG and to provide automatic calculation of key ECG indicators (Left Ventricular Activation time (LVAT) and V6-V1 interval) for LBB implantation procedure. This allows physicians to concentrate on lead placement with the benefice from immediate ECG measurements thanks to the automatic software.

The Smart ECG system is class IIA device and it is composed of:

  1. CE-marked Smart ECG, Class IIa medical device (rule 10 Annex VIII of MDR)
  2. ECG viewer Software (HookUp SmarV2) (providing 12 lead ECG display + automatic interval measurements + shadow plot for QRS visualization) Class IIa medical device (rule 11 Annex VIII of MDR).
  3. CE -marked 12 leads ECG cables radiotransparent and defibrillation proof (Class I device)
  4. Commercial PC used in combination with the devices under evaluation

The study is a pre-market, non-pivotal study: HookUp Smart V2 software is a non-implantable Class IIA device, with no interaction with the human body and the demonstration of conformity with general safety and performance requirements is based on the results of non-clinical testing methods alone (as article 61(10) from MDR.

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • France
      • Besançon, France, France, 25030
        • Not yet recruiting
        • CHU de Besançon
        • Contact:
      • Clermont-Ferrand, France, France, 63003
      • Grenoble, France, France, 38043
      • Montpellier, France, France, 34000
        • Recruiting
        • Clinique du Millénaire
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Subject with indication for LBBAP using an Electrophysiology ECG monitoring system (EP System) as part of pacemaker or CRT-P or CRT-D implant procedure (de novo implant, device revision or upgrade including LOT-CRT)
  • Subject signed and dated the ICF

Exclusion Criteria:

  • Incapacitated subject or under guardianship
  • inability to understand the purpose of the study
  • Minor subjects
  • Non menopausal women
  • Patients implanted with other electrically active non cardiac devices.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Use of Smart ECG system in subject with indication for LBBAP
Smart ECG system will be used in addition to EP system in subjects with indication for LBBAP
Device: LBBAP implant
Use of Smart ECG system during the LBB implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Capability to monitor LBB success criteria with the use of Smart ECG system
Time Frame: baseline/ procedure
Proportion of investigators providing an overall favorable assessment (assessed "GOOD or ACCEPTABLE") on a four- point scale (GOOD, ACCEPTABLE, POOR, VERY POOR) on the use of Smart ECG system to achieve LBB area pacing.
baseline/ procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The accuracy of the two measurements (LVAT and V6-V1)
Time Frame: baseline/ procedure
The accuracy of the two measurements (LVAT and V6-V1) during the final LBB lead position (LBBAP) will be assessed separately by comparing manual and automatic methods.
baseline/ procedure
Identification of LBB transitions
Time Frame: baseline/ procedure
Concordance between EP and Smart ECG for the identification of LBB transitions (non-selective to selective or non-selective to LVSP, during threshold test at final lead position)
baseline/ procedure
Type of LBB capture
Time Frame: baseline/ procedure
Concordance of type of LBB capture as determined by EP vs Smart ECG signals (LBBAP, likely LBBAP, LVSP) - based on centralized blinded review of EP annotated screenshot and Smart ECG recordings
baseline/ procedure
Signal quality analysis
Time Frame: baseline/ procedure
Comparison of Smart ECG versus EP signal quality analysis (signal to noise ratio, frequency analyses)
baseline/ procedure
Investigator's satisfaction
Time Frame: baseline/ procedure
Investigator's satisfaction questionnaire about using Smart ECG system during the full procedure (i.e .setting the system for the procedure, monitoring lead progression, assessing pacing capture)
baseline/ procedure
Safety reporting
Time Frame: baseline/ procedure
To report any SADE, ADE, DD occurred during the investigational procedure
baseline/ procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MicroPort CRM

Investigators

  • Principal Investigator: Dr Pierre- Antoine Catalan, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2025

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Estimated)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WSEN01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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