Portable ECG assistant to monitor left bundle branch area pacing during device implantation
Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution
This tests a portable ECG system that automatically measures key heart timing intervals to help doctors during left bundle branch area pacing implants for people getting pacemakers or CRT devices.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MicroPort CRM Industry-sponsored |
| Locations | 4 sites (Besançon, France and 3 other locations) |
| Trial ID | NCT07254013 on ClinicalTrials.gov |
What this trial studies
This is a pre-market, non-pivotal study of a portable Smart ECG system composed of a 12-lead display, radiotransparent ECG cable, and automatic interval-measurement software used during pacing lead placement in the interventricular septum. The software automatically calculates Left Ventricular Activation Time (LVAT) and the V6–V1 interval and provides a visual shadow plot of the QRS to support decisions about capture. The device is Class IIa and non-implantable, and the study will compare the system's automatic measurements to usual electrophysiology monitoring during de novo implants, revisions, or upgrades including CRT and LOT-CRT. The goal is to determine whether the system reliably provides immediate ECG measurements that let physicians focus on accurate lead positioning.
Who should consider this trial
Good fit: Adults who need left bundle branch area pacing as part of a pacemaker or CRT-P/CRT-D implantation (including new implants, revisions, or upgrades) and who can give informed consent are ideal candidates.
Not a fit: Minors, incapacitated patients, those who cannot understand the study, non-menopausal women, and patients with other electrically active non-cardiac implanted devices are excluded and would not benefit from participation.
Why it matters
Potential benefit: If successful, the system could give immediate, automated ECG measurements during implantation that may speed decision-making and improve accuracy of lead placement.
How similar studies have performed: ECG criteria such as LVAT and V6–V1 interval are established in the literature for identifying left bundle branch capture, but this specific portable automatic-monitoring assistant is a novel, non-pivotal device-level evaluation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Besançon, France and 3 other locations
- CHU de Besançon — Besançon, France, France (Not_yet_recruiting)
- Clermont Ferrand — Clermont-Ferrand, France, France (Recruiting)
- CHU Grenoble Alpes — Grenoble, France, France (Not_yet_recruiting)
- Clinique du Millénaire — Montpellier, France, France (Recruiting)
Study contacts
- Principal investigator: Dr Pierre- Antoine Catalan — University Hospital, Clermont-Ferrand
- Study coordinator: Maria Martino, Project Manager
- Email: maria.martino@crm.microport.com
- Phone: +393351005007
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.