RecruitingNot ApplicableNCT07254013
Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution
Sponsor
MicroPort CRM
Enrollment
55 participants
Start Date
Nov 14, 2025
Study Type
INTERVENTIONAL
Conditions
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
Eligibility
Min Age: 18 Years
Inclusion Criteria2
- 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 Criteria5
- 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.
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Interventions
DEVICELBBAP implant
Use of Smart ECG system during the LBB implant
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT07254013
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