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

NCT05553431 | Unknown DMC

• 1 other identifier: FirstWenzhouMU078
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Left Bundle Branch Pacing

Keywords

Left Bundle Branch Pacing

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Procedure duration

  Immediate Postoperative

• Fluoroscopy time

  Immediate Postoperative

• Change of threshold(V/0.5ms) from immediate postoperative

  3 months

• Change of LVEF(%) from baseline

  3 months

• Change of impedance(Ω) from immediate postoperative

  3 months

Study Arms (1)

No EP system Group

EXPERIMENTAL

Patients were performed left bundle branch pacing without EP system.

Device: Left bundle branch pacing

Interventions

Left bundle branch pacing DEVICE

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

No EP system Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

First Affliated Hospital, Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 33426907 BACKGROUND

• 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.

  PMID: 31136869 BACKGROUND

• 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.

  PMID: 29173611 BACKGROUND

Study Officials

• Weijian Huang, MD

  Wenzhou 1st Affliated Hopsital, Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weijian Huang, MD

CONTACT

+86 138-0669-1086; weijianhuang69@126.com

Lan Su, MD

CONTACT

+86 137-3874-2616; 2512057600@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: September 23, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: starting 6 months after publication

Locations

CN (1)