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

• Sponsor: First Affiliated Hospital of Wenzhou Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05553431
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Left Bundle Branch Pacing	Device: Left bundle branch pacing	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility of Simplified Permanent Left Bundle Branch Pacing (LBBP) Without Electrophysiological Recording System
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Successful rate [Immediate Postoperative]

   Success rate of left bundle branch pacing without EP system

2. Judgment coincidence rate [Intraoperative]

   Coincidence rate between the judgment made by the operator through ECG and PSA with EP system.

3. Intraoperative complications [Immediate Postoperative]

   Intraoperative complications were recorded

4. Postoperative complications [3 months]

   Postoperative complications were recorded

Secondary Outcome Measures

1. Procedure duration [Immediate Postoperative]

   Total time required for operation

2. Fluoroscopy time [Immediate Postoperative]

   Intraoperative time of radiation use

3. Change of threshold(V/0.5ms) from immediate postoperative [3 months]

   Threshold for capturing left bundle branch during unipolar pacing

4. Change of LVEF(%) from baseline [3 months]

   LVEF changes before and after surgery

5. Change of impedance(Ω) from immediate postoperative [3 months]

   Impedance during unipolar pacing

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affliated Hospital, Wenzhou Medical University	Wenzhou	Zhejiang	China	325000

Sponsors and Collaborators

• First Affiliated Hospital of Wenzhou Medical University

Investigators

• Principal Investigator: Weijian Huang, MD, Wenzhou 1st Affliated Hopsital, Wenzhou Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: First Affiliated Hospital of Wenzhou Medical University
• ClinicalTrials.gov Identifier: NCT05553431
• Other Study ID Numbers: FirstWenzhouMU078
• First Posted: Sep 23, 2022
• Last Update Posted: Sep 23, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by First Affiliated Hospital of Wenzhou Medical University: Left Bundle Branch Pacing

Study Results

No Results Posted as of Sep 23, 2022