Long-term Efficacy and Safety Research of Left Bundle Branch Pacing

Patients with successful left bundle branch pacing in our center were included in this study from April 2018 to December 2019. Baseline data was collected, and pacing parameters, ECG and echocardiographic results were analyzed during 3 years follow-up. According to whether or not a potential was recorded and the specific potential characteristics at implantation, the patients were divided into 3 groups: left bundle branch potential group; Purkinje potential group; and no-potential group. During the 3 years follow-up, the investigators collected the ECG、UCG and pacemaker parameters to analyze.

Study Overview

• Status: Completed
• Conditions: Atrioventricular Block; Left Bundle Branch Pacing
• Intervention / Treatment: Device: Cardiac pacemaker and Select Secure lead

Detailed Description

A total of 136 patients with a high percentage of ventricular pacing and successful left bundle branch pacing were included in this study from April 2018 to December 2019. Baseline data was collected, and pacing parameters, ECG and echocardiographic results were analyzed during 3 years follow-up. According to whether or not a potential was recorded and the specific potential characteristics at implantation, the patients were divided into 3 groups: left bundle branch potential group (L group) 31.6%; Purkinje potential group (P group) 10.3%; and no-potential group (N group) 58.1%. During the 3 years follow-up, the investigators collected the ECG、UCG and pacemaker parameters to analyze.

• Study Type: Observational
• Enrollment (Actual): 136

Contacts and Locations

Study Locations

• China
  • Shandong
    • Linyi, Shandong, China, 276000
      • Linyi People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

From April 2018 to Dec 2019, consecutive patients who were predicted to require a high percentage of ventricular pacing in our center were enrolled in this study. Main indications for the enrolment of patients are atrioventricular block and heart failure (HF) combined with complete left bundle branch block (LBBB). All patients were accorded with indications for pacing therapy of 2013 European Society of Cardiology guidelines on cardiac pacing. The study conforms to the guiding principles of the Declaration of Helsinki and was approved by Ethics Committee of the Linyi People's Hospital. All patients signed the informed consent.

Description

Inclusion Criteria:

• Patients who were predicted to require a high percentage of ventricular pacing in our center were enrolled in this study

Exclusion Criteria:

• Low rate of pacing, and loss to follow-up

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
left bundle branch potential group; the left bundle branch potential was recorded at implantation	Device: Cardiac pacemaker and Select Secure lead; model 3830, 69cm, Medtronic, Inc., Minneapolis, MN, USA
Purkinje potential group; the purkinje potential was recorded at implantation	Device: Cardiac pacemaker and Select Secure lead; model 3830, 69cm, Medtronic, Inc., Minneapolis, MN, USA
no-potential group; no potential was recorded at implantation	Device: Cardiac pacemaker and Select Secure lead; model 3830, 69cm, Medtronic, Inc., Minneapolis, MN, USA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in left atrium diameter at 3 years	Echocardiography is measured by a professional using an ultrasound machine, record the following results: left atrium diameter (ms)	Baseline and 3 years
Change from Baseline in left ventricular end diastolic diameter at 3 years	Left ventricular end diastolic diameter (ms)	Baseline and 3 years
Change from Baseline in left ventricular ejection fraction at 3 years	Left ventricular ejection fraction (%)	Baseline and 3 years
Change from Baseline in pulmonary artery systolic pressure at 3 years	Pulmonary artery systolic pressure (mmHg)	Baseline and 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in threshold at 3 years	Threshold was measured with a pace-sensing analyser: threshold (V) at 0.5ms	Baseline and 3 years
Change from Baseline in impedance at 3 years	Impedance was measured with a pace-sensing analyser: impedance(Ω)	Baseline and 3 years

Collaborators and Investigators

• Sponsor: Linyi People's Hospital
• Investigators: Study Chair: Fingming Li, Linyi People's Hospital

Publications and helpful links

General 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.
• Hou X, Qian Z, Wang Y, Qiu Y, Chen X, Jiang H, Jiang Z, Wu H, Zhao Z, Zhou W, Zou J. Feasibility and cardiac synchrony of permanent left bundle branch pacing through the interventricular septum. Europace. 2019 Nov 1;21(11):1694-1702. doi: 10.1093/europace/euz188.
• Huang W, Chen X, Su L, Wu S, Xia X, Vijayaraman P. A beginner's guide to permanent left bundle branch pacing. Heart Rhythm. 2019 Dec;16(12):1791-1796. doi: 10.1016/j.hrthm.2019.06.016. Epub 2019 Jun 22. No abstract available.
• 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.
• Ponnusamy SS, Muthu G, Kumar M, Bopanna D, Anand V, Kumar S. Mid-term feasibility, safety and outcomes of left bundle branch pacing-single center experience. J Interv Card Electrophysiol. 2021 Mar;60(2):337-346. doi: 10.1007/s10840-020-00807-w. Epub 2020 Jul 4.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 30, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Block; Atrioventricular Block
• Other Study ID Numbers: Linyi People's Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: all collected IPD would be shared after publishing

Drug and device information, study documents

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