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

NCT07254013 | Recruiting

• 1 other identifier: WSEN01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Bradycardia; Left Bundle Branch Area Pacing; Cardiac Resynchronisation Therapy (CRT); ECG

Keywords

LBBAP ECG MONITORING ASSISTANT

Outcome Measures

Primary Outcomes (1)

• Capability to monitor LBB success criteria with the use of Smart ECG system

  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 Outcomes (6)

• The accuracy of the two measurements (LVAT and V6-V1)

  baseline/ procedure

• Identification of LBB transitions

  baseline/ procedure

• Type of LBB capture

  baseline/ procedure

• Signal quality analysis

  baseline/ procedure

• Investigator's satisfaction

  baseline/ procedure

Study Arms (1)

Use of Smart ECG system in subject with indication for LBBAP

EXPERIMENTAL

Smart ECG system will be used in addition to EP system in subjects with indication for LBBAP

Device: LBBAP implant

Interventions

LBBAP implant DEVICE

Use of Smart ECG system during the LBB implant

Use of Smart ECG system in subject with indication for LBBAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• MicroPort CRM: lead

Study Sites (4)

CHU de Besançon

Besançon, France, 25030, France

NOT YET RECRUITING

Clermont Ferrand

Clermont-Ferrand, France, 63003, France

RECRUITING

CHU Grenoble Alpes

Grenoble, France, 38043, France

NOT YET RECRUITING

Clinique du Millénaire

Montpellier, France, 34000, France

RECRUITING

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Pierre- Antoine Catalan

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Martino, Project Manager

CONTACT

+393351005007; maria.martino@crm.microport.com

Study Design

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

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: November 14, 2025
• Primary Completion: February 28, 2026
• Study Completion: March 31, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-10

Locations

FR (4)