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

Wenzhou Medical University

Status: Not yet enrolling

Conditions: Left Bundle Branch Pacing; Atrioventricular Block, Second and Third Degree; Heart Failure

Treatments: Device: Bi-ventricular pacing; Device: Left bundle branch pacing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05553626

FirstWenzhouMU216-02

Details and patient eligibility

About

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

Full 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

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

LBBP Treatment

Experimental group

Description:

Patients were performed left bundle branch pacing by a single/dual chamber pacemaker or dual chamber ICD device

Treatment:

Device: Left bundle branch pacing

Device: Bi-ventricular pacing

BVP Treatment

Active Comparator group

Description:

Patients were performed bi-ventricular pacing by a CRT/CRTD device

Treatment:

Device: Left bundle branch pacing

Device: Bi-ventricular pacing