Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMicroPort CRM
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
Incapacitated subject or under guardianship
inability to understand the purpose of the study
Minor subjects
Non menopausal women
Trial design
Treatments tested in this trial
- LBBAP implant
Treatment groups
55 Participants
are divided into 1 treatment groupLocations
4CHU de Besançon25030, BesançonFrance, France
Clermont Ferrand63003, Clermont-FerrandFrance, France
CHU Grenoble Alpes38043, GrenobleFrance, France
Clinique du Millénaire34000, MontpellierFrance, France
Sponsors and collaborators
MicroPort CRM
Lead sponsor
Source ClinicalTrials.gov