Actively Recruiting
Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution
Led by MicroPort CRM · Updated on 2025-12-05
55
Participants Needed
4
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the ability to monitor Left Bundle Branch Area Pacing (LBBAP) success criteria using a Smart ECG system during cardiac device implantation. The study focuses on supporting physicians by providing a portable, easy-to-use ECG display and automatic calculation of key ECG indicators such as Left Ventricular Activation Time (LVAT) and V6-V1 interval. This helps doctors concentrate on lead placement with immediate ECG measurements provided by the software. The Smart ECG system consists of a CE-marked Class IIa device, including an ECG monitor, 12-lead ECG cables, ECG viewer software (HookUp Smart V2), and a commercial PC to display and analyze ECG data. The system is used alongside an Electrophysiology ECG monitoring system during pacemaker or cardiac resynchronization therapy (CRT) implantation involving the placement of a pacing lead in the interventricular septum. The study is pre-market and non-pivotal, focusing on device performance and safety based on non-clinical testing. Participants with an indication for LBBAP will undergo the procedure with the Smart ECG system used in addition to the standard EP system. Researchers will assess the capability to monitor LBB success criteria, accuracy of key ECG measurements, identification of LBB transitions, type of LBB capture, signal quality, investigator satisfaction, and safety during the procedure. The study includes baseline and procedure evaluations, with participants followed through the implant process to gather these outcomes.
CONDITIONS
Brief Title
Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject with indication for LBBAP using an Electrophysiology ECG monitoring 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 informed consent form
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo the LBBAP implant procedure using the Smart ECG system as part of their standard care.
1 visit (in-person)
Trial Site Locations
Total: 4 locations
1
CHU de Besançon
Besançon, France, France, 25030
Not Yet Recruiting
2
Clermont Ferrand
Clermont-Ferrand, France, France, 63003
Actively Recruiting
3
CHU Grenoble Alpes
Grenoble, France, France, 38043
Not Yet Recruiting
4
Clinique du Millénaire
Montpellier, France, France, 34000
Actively Recruiting
Research Team
M
Maria Martino, Project Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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