BradycardiaLBBOTNCT07254013
Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution
A study testing LBBAP implant in people with Bradycardia and Left Bundle Branch Area Pacing, run by MicroPort CRM at 4 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bradycardia, Left Bundle Branch Area Pacing, Cardiac Resynchronisation Therapy (CRT)
- What is being tested?
- LBBAP implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 4 sitesFrance
- Study dates
- 14 Nov 2025to 12 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU de Besançon
Besançon, France, 25030
Clermont Ferrand
Clermont-Ferrand, France, 63003
CHU Grenoble Alpes
Grenoble, France, 38043
Clinique du Millénaire
Montpellier, France, 34000
About this study
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
Read the 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:
- CE-marked Smart ECG, Class IIa medical device (rule 10 Annex VIII of MDR)
- 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).
- CE -marked 12 leads ECG cables radiotransparent and defibrillation proof (Class I device)
- 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.
- Being tested
- LBBAP implant
- Keywords
- LBBAP ECG MONITORING ASSISTANT
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBBAP implantDevice
Use of Smart ECG system during the LBB implant
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: LBBAP implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline/ procedure
Secondary outcomes (6)
The accuracy of the two measurements (LVAT and V6-V1)
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.
Measured: baseline/ procedure
Identification of LBB transitions
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)
Measured: baseline/ procedure
Type of LBB capture
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
Measured: baseline/ procedure
Signal quality analysis
Comparison of Smart ECG versus EP signal quality analysis (signal to noise ratio, frequency analyses)
Measured: baseline/ procedure
Investigator's satisfaction
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)
Measured: baseline/ procedure
Safety reporting
To report any SADE, ADE, DD occurred during the investigational procedure
Measured: baseline/ procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start14 Nov 2025
- Primary completion21 Apr 2026
- Study completion12 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort CRM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Pierre- Antoine Catalan, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254013
- Sponsor's protocol ID
- WSEN01
- Acronym
- LBBOT
- Status last verified
- Oct 2025
- First submitted
- 19 Nov 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution
- ClinicalTrials.gov ID
- NCT07254013
- Acronym / sponsor ID
- LBBOT / WSEN01
- Keywords
- LBBAP ECG MONITORING ASSISTANT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- MicroPort CRMIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- CE-marked Smart ECG, Class IIa medical device (rule 10 Annex VIII of MDR)
- 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).
- CE -marked 12 leads ECG cables radiotransparent and defibrillation proof (Class I device)
- 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of Smart ECG system in subject with indication for LBBAP | Experimental | Device: LBBAP implantSmart ECG system will be used in addition to EP system in subjects with indication for LBBAP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LBBAP implantUse of Smart ECG system during the LBB implant | Device | Use of Smart ECG system in subject with indication for LBBAP |
Primary outcome
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.
6 secondary outcomes
The accuracy of the two measurements (LVAT and V6-V1)
Time frame: baseline/ procedure
Identification of LBB transitions
Time frame: baseline/ procedure
Type of LBB capture
Time frame: baseline/ procedure
Signal quality analysis
Time frame: baseline/ procedure
Investigator's satisfaction
Time frame: baseline/ procedure
Safety reporting
Time frame: baseline/ procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
Related trials for Bradycardia
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
RecruitingObservational study
Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
Pacemaker, Leadless Pacemaker
RecruitingObservational study
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Arrhythmia, Bradycardia
Active, not recruitingObservational study
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Bradycardia, Atrioventricular Block
RecruitingObservational study
BIO|STREAM.CSP Study
Cardiac Pacing, Cardiac Pacemaker
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Pierre- Antoine Catalan principal investigator
University Hospital, Clermont-Ferrand
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LBBAP implant in people with Bradycardia and Left Bundle Branch Area Pacing, run by MicroPort CRM at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capability to monitor LBB success criteria with the use of Smart ECG system (time frame: baseline/ procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.