Feasibility of Simplified Permanent Left Bundle Branch Pacing Without Electrophysiological Recording System

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility of Simplified Permanent Left Bundle Branch Pacing (LBBP) Without Electrophysiological Recording System

Conditions
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Left Bundle Branch Pacing

Intervention / Treatment
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* Device: Left bundle branch pacing


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No EP system Group<br>Patients were performed left bundle branch pacing without EP system. | Device: Left bundle branch pacing<br>* Left bundle branch pacing by a CRT device or dual-chamber pacemaker through the pacing lead at left bundle branch region<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful rate | Success rate of left bundle branch pacing without EP system | Immediate Postoperative | 
| Judgment coincidence rate | Coincidence rate between the judgment made by the operator through ECG and PSA with EP system. | Intraoperative | 
| Intraoperative complications | Intraoperative complications were recorded | Immediate Postoperative | 
| Postoperative complications | Postoperative complications were recorded | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure duration | Total time required for operation | Immediate Postoperative | 
| Fluoroscopy time | Intraoperative time of radiation use | Immediate Postoperative | 
| Change of threshold(V/0.5ms) from immediate postoperative | Threshold for capturing left bundle branch during unipolar pacing | 3 months | 
| Change of LVEF(%) from baseline | LVEF changes before and after surgery | 3 months | 
| Change of impedance(Ω) from immediate postoperative | Impedance during unipolar pacing | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left Bundle Branch Pacing