Clinical trial NCT05600699: Long-term Efficacy and Safety Research of Left Bundle Branch Pacing
Official title: Long-term Efficacy and Safety Research of Left Bundle Branch Pacing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrioventricular Block
Left Bundle Branch Pacing
Lead sponsor: Linyi People's Hospital
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 136
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in left atrium diameter at 3 years
timeFrame: Baseline and 3 years
measure: Change from Baseline in left ventricular end diastolic diameter at 3 years
timeFrame: Baseline and 3 years
measure: Change from Baseline in left ventricular ejection fraction at 3 years
timeFrame: Baseline and 3 years
measure: Change from Baseline in pulmonary artery systolic pressure at 3 years
timeFrame: Baseline and 3 years
Secondary outcomes:
measure: Change from Baseline in threshold at 3 years
timeFrame: Baseline and 3 years
measure: Change from Baseline in impedance at 3 years
timeFrame: Baseline and 3 years
Other outcomes:
Locations:
city: Linyi
country: China
facility: Linyi People's Hospital
state: Shandong
Study officials:
affiliation: Linyi People's Hospital
name: Fingming Li
role: STUDY_CHAIR
References:
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. No abstract available.
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.
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.
citation: 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.
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.