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

Atrioventricular Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05600699
• Other study ID #: Linyi People's Hospital
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2022
• Source: Linyi People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: October 1, 2022
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrioventricular Block

Intervention

Device:
• Cardiac pacemaker and Select Secure lead
model 3830, 69cm, Medtronic, Inc., Minneapolis, MN, USA

Locations

Country	Name	City	State
China	Linyi People's Hospital	Linyi	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Linyi People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from Baseline in left ventricular end diastolic diameter at 3 years	Left ventricular end diastolic diameter (ms)	Baseline and 3 years
Primary	Change from Baseline in left ventricular ejection fraction at 3 years	Left ventricular ejection fraction (%)	Baseline and 3 years
Primary	Change from Baseline in pulmonary artery systolic pressure at 3 years	Pulmonary artery systolic pressure (mmHg)	Baseline and 3 years
Secondary	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
Secondary	Change from Baseline in impedance at 3 years	Impedance was measured with a pace-sensing analyser: impedance(O)	Baseline and 3 years