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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05553431
Enrollment
100
Registered
2022-09-23
Start date
2022-09-30
Completion date
2023-12-31
Last updated
2022-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left Bundle Branch Pacing

Keywords

Left Bundle Branch Pacing

Brief summary

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

Detailed 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.

Interventions

Left bundle branch pacing by a CRT device or dual-chamber pacemaker through the pacing lead at left bundle branch region

Sponsors

First Affiliated Hospital of Wenzhou Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Successful rateImmediate PostoperativeSuccess rate of left bundle branch pacing without EP system
Judgment coincidence rateIntraoperativeCoincidence rate between the judgment made by the operator through ECG and PSA with EP system.
Intraoperative complicationsImmediate PostoperativeIntraoperative complications were recorded
Postoperative complications3 monthsPostoperative complications were recorded

Secondary

MeasureTime frameDescription
Procedure durationImmediate PostoperativeTotal time required for operation
Change of impedance(Ω) from immediate postoperative3 monthsImpedance during unipolar pacing
Fluoroscopy timeImmediate PostoperativeIntraoperative time of radiation use
Change of threshold(V/0.5ms) from immediate postoperative3 monthsThreshold for capturing left bundle branch during unipolar pacing
Change of LVEF(%) from baseline3 monthsLVEF changes before and after surgery

Countries

China

Contacts

Primary ContactWeijian Huang, MD
weijianhuang69@126.com+86 138-0669-1086
Backup ContactLan Su, MD
2512057600@qq.com+86 137-3874-2616

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026