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

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

Study Overview

• Status: Recruiting
• Conditions: Left Bundle Branch Pacing
• Intervention / Treatment: Device: Left bundle branch pacing

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weijian Huang, MD; Phone Number: +86 138-0669-1086; Email: weijianhuang69@126.com

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • First Affliated Hospital, Wenzhou Medical University
      • Contact: Weijian Huang, MD; Phone Number: +86 138-0669-1086; Email: weijianhuang69@126.com
      • Contact: Lan Su; Phone Number: +86 137-3874-2616; Email: 2512057600@qq.com
      • Sub-Investigator: Lan Su, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: No EP system Group; Patients were performed left bundle branch pacing without EP system.	Device: Left bundle branch pacing; Left bundle branch pacing by a CRT device or dual-chamber pacemaker through the pacing lead at left bundle branch region

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Wenzhou Medical University

Publications and helpful links

General Publications

• Su L, Wang S, Wu S, Xu L, Huang Z, Chen X, Zheng R, Jiang L, Ellenbogen KA, Whinnett ZI, Huang W. Long-Term Safety and Feasibility of Left Bundle Branch Pacing in a Large Single-Center Study. Circ Arrhythm Electrophysiol. 2021 Feb;14(2):e009261. doi: 10.1161/CIRCEP.120.009261. Epub 2021 Jan 9.
• Vijayaraman P, Subzposh FA, Naperkowski A, Panikkath R, John K, Mascarenhas V, Bauch TD, Huang W. Prospective evaluation of feasibility and electrophysiologic and echocardiographic characteristics of left bundle branch area pacing. Heart Rhythm. 2019 Dec;16(12):1774-1782. doi: 10.1016/j.hrthm.2019.05.011. Epub 2019 May 25.
• Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Ellenbogen KA. A Novel Pacing Strategy With Low and Stable Output: Pacing the Left Bundle Branch Immediately Beyond the Conduction Block. Can J Cardiol. 2017 Dec;33(12):1736.e1-1736.e3. doi: 10.1016/j.cjca.2017.09.013. Epub 2017 Sep 22.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2022
• Primary Completion (ANTICIPATED): September 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (ACTUAL): September 23, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Left Bundle Branch Pacing
• Other Study ID Numbers: FirstWenzhouMU078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No