Clinical trial NCT05553431: Feasibility of Simplified Permanent Left Bundle Branch Pacing Without Electrophysiological Recording System
Official title: Feasibility of Simplified Permanent Left Bundle Branch Pacing (LBBP) Without Electrophysiological Recording System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Left Bundle Branch Pacing
Keywords: Left Bundle Branch Pacing
Lead sponsor: First Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-center study of patients with an indication for ventricular pacing who attempted LBBP without electrophysiology recording system (EP system).

Detailed description: Patients who meet the inclusion and exclusion criteria will be enrolled into the study. In the study, the implanter was blinded to EP system, only refer to ECG monitoring. The transition of QRS morphology from S-LBBP (or LVSP) to NS-LBBP, abrupt shortening of Stim-LVAT in lead V5, combined with LV septal-derived PVCs and obvious LBB potential in pacing system analyzer were recorded to help the implanter confirm LBB capture. Meanwhile, the technician recorded the data by EP system and evaluated the consistency of the judgment. The primary endpoints included the success rate, procedure-related information, parameters and complications during 3-month follow-up.

Eligibility criteria: Inclusion Criteria:

* (1) requiring ventricular pacing; (2) older than 18 years; (3) signed informed consent.

Exclusion Criteria:

* (1) acute anterior myocardial infarction; (2) intraventricular conduction delay (IVCD); (3) ventricular septal hypertrophy (end-diastolic thickness over 15 mm).

Primary outcomes:
measure: Successful rate
timeFrame: Immediate Postoperative
measure: Judgment coincidence rate
timeFrame: Intraoperative
measure: Intraoperative complications
timeFrame: Immediate Postoperative
measure: Postoperative complications
timeFrame: 3 months
Secondary outcomes:
measure: Procedure duration
timeFrame: Immediate Postoperative
measure: Fluoroscopy time
timeFrame: Immediate Postoperative
measure: Change of threshold(V/0.5ms) from immediate postoperative
timeFrame: 3 months
measure: Change of LVEF(%) from baseline
timeFrame: 3 months
measure: Change of impedance(Ω) from immediate postoperative
timeFrame: 3 months
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: First Affliated Hospital, Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Wenzhou 1st Affliated Hopsital, Wenzhou Medical University
name: Weijian Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: Vijayaraman P, Subzposh FA, Naperkowski A, Panikkath R, John K, Mascarenhas V, Bauch TD, Huang W. Prospective evaluation of feasibility and electrophysiologic and echocardiographic characteristics of left bundle branch area pacing. Heart Rhythm. 2019 Dec;16(12):1774-1782. doi: 10.1016/j.hrthm.2019.05.011. Epub 2019 May 25.
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.