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

Not Applicable

Not yet recruiting

• Conditions: Atrioventricular Block, Second and Third Degree; Heart Failure; Left Bundle Branch Pacing
• Interventions: Device: Left bundle branch pacing; Device: Bi-ventricular pacing

• Registration Number: NCT05553626
• Lead Sponsor: First Affiliated Hospital of Wenzhou Medical University

Brief 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

Study Timeline

• Status Verified: 2022-07
• Study Start: 2022-09
• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-21
• Last Update Submitted: 2022-09-21
• Study First Posted: 2022-09-23
• Last Update Posted: 2022-09-23
• Primary Completion: 2024-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Above 18 years old
• Agree to participate in trial and sign informed consent
• NYHA cardiac function class I-III
• LVEF<50%
• Second or complete atrioventricular block with pacing indication or ventricular pacing dependent with ventricular pacing percentage >40%
• Patients who are willing to take the de-novo implant or device replacement or upgrade.

Exclusion Criteria

• Life expectancy <1 year
• Patients with severe tricuspid valvular disease1 or who have undergone mechanical valve or bioprosthetic valve surgery
• Acute myocardial infarction within 1 month
• Women of childbearing age who are pregnant or becoming pregnant during the study period
• Severe liver and kidney dysfunction2
• Have been enrolled in another clinical studies that may interferes with the current trial objectives
• Evidence of severe pulmonary hypertension (PASP>70mmHg)
• Evidence of hypertrophic cardiomyopathy which shall affect the prognosis of patients.
• The investigator believes that subject's physical condition is not suitable for participation in the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LBBP Treatment	Bi-ventricular pacing	Patients were performed left bundle branch pacing by a single/dual chamber pacemaker or dual chamber ICD device
BVP Treatment	Bi-ventricular pacing	Patients were performed bi-ventricular pacing by a CRT/CRTD device
LBBP Treatment	Left bundle branch pacing	Patients were performed left bundle branch pacing by a single/dual chamber pacemaker or dual chamber ICD device
BVP Treatment	Left bundle branch pacing	Patients were performed bi-ventricular pacing by a CRT/CRTD device

Primary Outcome Measures

Name	Time	Method
Change of LVEF	12 months	To compare the effects of LBBP Treatment Group and CRT Treatment Group on target subjects by analyzing the LVEF within 12 months post-implant.

Secondary Outcome Measures

Name	Time	Method
Change of LVESV	12 months	To demonstrate and compare the LVESV at 12 month post-implant.
successful rate	12 months	To characterize the successful rate of LBBP Procedure and CRT Procedure among randomized patients' group.
mortality and heart failure hospitalization rate	12 months	To demonstrate and compare the mortality and heart failure hospitalization rate between LBBP and CRT treatment group 12 month post-implant
occurrence of serious complication associated with LBBP procedure	12 months	To characterize occurrence of serious complication associated with LBBP procedure within 12 month post-implant.
QRS width between LBBP and CRT	12 months	To characterize and compare the QRS width between LBBP and CRT treatment groups during the baseline, preoperative, postoperative and follow up visits within 3 months and 12 month post-implant.
incidence and severity of tricuspid regurgitation	12 months	To assess and compare the incidence and severity of tricuspid regurgitation between LBBP and CRT treatment groups within 12 month post-implant

Trial Locations

Locations (1)

First Affliated Hospital, Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China