NCT05553431

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: First Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Left Bundle Branch Pacing

Interventions

Type	Name	Description
DEVICE	Left bundle branch pacing	Left bundle branch pacing by a CRT device or dual-chamber pacemaker through the pacing lead at left bundle branch region

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-09-01
• Completion: 2023-12-01
• First posted: 2022-09-23
• Last updated: 2022-09-23

Locations

1 site across 1 country: China