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Feasibility of Simplified Permanent Left Bundle Branch Pacing Without Electrophysiological Recording System

W

Wenzhou Medical University

Status

Enrolling

Conditions

Left Bundle Branch Pacing

Treatments

Device: Left bundle branch pacing

Study type

Interventional

Funder types

Other

Identifiers

NCT05553431
FirstWenzhouMU078

Details and patient eligibility

About

This is a prospective, single-center study of patients with an indication for ventricular pacing who attempted LBBP without electrophysiology recording system (EP system).

Full description

Patients who meet the inclusion and exclusion criteria will be enrolled into the study. In the study, the implanter was blinded to EP system, only refer to ECG monitoring. The transition of QRS morphology from S-LBBP (or LVSP) to NS-LBBP, abrupt shortening of Stim-LVAT in lead V5, combined with LV septal-derived PVCs and obvious LBB potential in pacing system analyzer were recorded to help the implanter confirm LBB capture. Meanwhile, the technician recorded the data by EP system and evaluated the consistency of the judgment. The primary endpoints included the success rate, procedure-related information, parameters and complications during 3-month follow-up.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • (1) requiring ventricular pacing; (2) older than 18 years; (3) signed informed consent.

Exclusion criteria

  • (1) acute anterior myocardial infarction; (2) intraventricular conduction delay (IVCD); (3) ventricular septal hypertrophy (end-diastolic thickness over 15 mm).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

No EP system Group
Experimental group
Description:
Patients were performed left bundle branch pacing without EP system.
Treatment:
Device: Left bundle branch pacing

Trial contacts and locations

1

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Central trial contact

Weijian Huang, MD; Lan Su, MD

Data sourced from clinicaltrials.gov

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