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

Not Applicable

• Conditions: Left Bundle Branch Pacing
• Interventions: Device: Left bundle branch pacing

• Registration Number: NCT05553431
• Lead Sponsor: First Affiliated Hospital of Wenzhou Medical University

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.

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-30
• Study Start: 2022-09
• Study First Submitted QC: 2022-09-21
• Last Update Submitted: 2022-09-21
• Study First Posted: 2022-09-23
• Last Update Posted: 2022-09-23
• Primary Completion: 2023-09
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
No EP system Group	Left bundle branch pacing	Patients were performed left bundle branch pacing without EP system.

Primary Outcome Measures

Name	Time	Method
Judgment coincidence rate	Intraoperative	Coincidence rate between the judgment made by the operator through ECG and PSA with EP system.
Successful rate	Immediate Postoperative	Success rate of left bundle branch pacing without EP system
Intraoperative complications	Immediate Postoperative	Intraoperative complications were recorded
Postoperative complications	3 months	Postoperative complications were recorded

Secondary Outcome Measures

Name	Time	Method
Change of impedance(Ω) from immediate postoperative	3 months	Impedance during unipolar pacing
Fluoroscopy time	Immediate Postoperative	Intraoperative time of radiation use
Change of threshold(V/0.5ms) from immediate postoperative	3 months	Threshold for capturing left bundle branch during unipolar pacing
Procedure duration	Immediate Postoperative	Total time required for operation
Change of LVEF(%) from baseline	3 months	LVEF changes before and after surgery

Trial Locations

Locations (1)

First Affliated Hospital, Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China