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

NCT ID: NCT05600699

Last Updated: 2022-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

136 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2022-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atrioventricular Block Left Bundle Branch Pacing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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left bundle branch potential group

the left bundle branch potential was recorded at implantation

Cardiac pacemaker and Select Secure lead

Intervention Type DEVICE

model 3830, 69cm, Medtronic, Inc., Minneapolis, MN, USA

Purkinje potential group

the purkinje potential was recorded at implantation

Cardiac pacemaker and Select Secure lead

Intervention Type DEVICE

model 3830, 69cm, Medtronic, Inc., Minneapolis, MN, USA

no-potential group

no potential was recorded at implantation

Cardiac pacemaker and Select Secure lead

Intervention Type DEVICE

model 3830, 69cm, Medtronic, Inc., Minneapolis, MN, USA

Interventions

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Cardiac pacemaker and Select Secure lead

model 3830, 69cm, Medtronic, Inc., Minneapolis, MN, USA

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Linyi People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xinhua Li

Deputy director of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fingming Li

Role: STUDY_CHAIR

Linyi People's Hospital

Locations

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Linyi People's Hospital

Linyi, Shandong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 31233818 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29173611 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33426907 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31322651 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32623624 (View on PubMed)

Other Identifiers

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Linyi People's Hospital

Identifier Type: -

Identifier Source: org_study_id

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