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

NCT05600699 | Completed FDA Device

• 1 other identifier: Linyi People's Hospital
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrioventricular Block; Left Bundle Branch Pacing

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Change from Baseline in threshold at 3 years

  Baseline and 3 years

• Change from Baseline in impedance at 3 years

  Baseline and 3 years

Study Arms (3)

left bundle branch potential group

the left bundle branch potential was recorded at implantation

Device: Cardiac pacemaker and Select Secure lead

Purkinje potential group

the purkinje potential was recorded at implantation

Device: Cardiac pacemaker and Select Secure lead

no-potential group

no potential was recorded at implantation

Device: Cardiac pacemaker and Select Secure lead

Interventions

Cardiac pacemaker and Select Secure lead DEVICE

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

Purkinje potential group; left bundle branch potential group; no-potential group

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Linyi People's Hospital: lead

Study Sites (1)

Linyi People's Hospital

Linyi, Shandong, 276000, China

Location

Related Publications (5)

• 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.

  PMID: 31233818 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

• 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

• 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.

  PMID: 31322651 BACKGROUND

• 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.

  PMID: 32623624 BACKGROUND

MeSH Terms

Conditions

Atrioventricular Block

Interventions

Pacemaker, Artificial

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrodes; Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Fingming Li

  Linyi People's Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of Cardiology

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 31, 2022
• Study Start: April 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: October 1, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Locations

CN (1)