An interventional study of LBBAP implant in Bradycardia, Left Bundle Branch Area Pacing and Cardiac Resynchronisation Therapy (CRT), sponsored by MicroPort CRM. Completed at 4 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by MicroPort CRM (part of MicroPort Scientific Corporation) · Not applicable, Interventional, and Other
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
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:
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.
317 studies on the registry are indexed under Bradycardia; 71 are open to participants now.
This study's enrollment of 55 is below the median of 100 across 187 interventional studies indexed under Bradycardia.
Browse Bradycardia studies →MicroPort CRM is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
First submitted after MicroPort CRM became part of MicroPort Scientific Corporation.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: baseline/ procedure
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.
Time frame: 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)
Time frame: 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
Time frame: baseline/ procedure
Signal quality analysis
Comparison of Smart ECG versus EP signal quality analysis (signal to noise ratio, frequency analyses)
Time frame: 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)
Time frame: baseline/ procedure
Safety reporting
To report any SADE, ADE, DD occurred during the investigational procedure
Time frame: baseline/ procedure
Ran from Nov 2025 to primary completion in Apr 2026, 5 months.
Of 36 industry-sponsored interventional studies with no phase under Bradycardia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 32. This study's 5 months is below that.
Counting every sponsor, half of 83 studies reached it within 21 months; a quarter within 12 and three quarters within 38.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 30, 2026: primary completion Feb 2026 → Apr 2026 and completion Mar 2026 → Jun 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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