NCT05553626

Safety and Effectiveness of Left Bundle Branch Pacing in Patients With Cardiac Dysfunction and AV Block

Safety and Effectiveness of Left Bundle Branch Pacing (LBBP) in Patients With Cardiac Dysfunction and AV Block

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: First Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, prospective, randomized study to assess if cardiac dysfunction patients with LVEF \<50% and the estimated ventricular pacing percentage \>40% with LBBP have the non-inferior safety and efficacy than CRT on patients' cardiac function and prognosis

Detailed description

Patients who meet the inclusion and exclusion criteria will be enrolled into the study. In the study, patients with cardiac dysfunction who met the enrollment criteria and will agree to participate in this trial will be 1:1 randomized to the LBBP group and the CRT group. Patients who were successfully implanted were enrolled for evaluation and follow-up. The primary end points of the study is the change of LVEF within 12 months post-implant in both LBBP Treatment Group and CRT Treatment Group

Conditions

• Atrioventricular Block, Second and Third Degree
• Heart Failure
• Left Bundle Branch Pacing

Interventions

Type	Name	Description
DEVICE	Left bundle branch pacing	Left bundle branch pacing by a single/dual chamber pacemaker or dual chamber ICD device through the pacing lead at left bundle branch region
DEVICE	Bi-ventricular pacing	Bi-ventricular pacing by a CRT/CRTD device

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-02-01
• Completion: 2025-02-01
• First posted: 2022-09-23
• Last updated: 2022-09-23

Locations

1 site across 1 country: China