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Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution

RECRUITINGN/ASponsored by MicroPort CRM
Actively Recruiting
PhaseN/A
SponsorMicroPort CRM
Started2025-11-14
Est. completion2026-02-28
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07254013

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions5

BradycardiaCardiac Resynchronisation Therapy (CRT)ECGHeart DiseaseLeft Bundle Branch Area Pacing

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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