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

First Affiliated Hospital of Wenzhou Medical University160 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

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

Interventions

Left bundle branch pacingDEVICE

Left bundle branch pacing by a single/dual chamber pacemaker or dual chamber ICD device through the pacing lead at left bundle branch region

Bi-ventricular pacingDEVICE

Bi-ventricular pacing by a CRT/CRTD device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

First Affliated Hospital, Wenzhou Medical University

Wenzhou, Zhejiang, China

Outcomes

Primary Outcomes

Change of LVEF

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

Time frame: 12 months

Secondary Outcomes

Change of LVESV

To demonstrate and compare the LVESV at 12 month post-implant.

Time frame: 12 months

successful rate

To characterize the successful rate of LBBP Procedure and CRT Procedure among randomized patients' group.

Time frame: 12 months

mortality and heart failure hospitalization rate

To demonstrate and compare the mortality and heart failure hospitalization rate between LBBP and CRT treatment group 12 month post-implant

Time frame: 12 months

occurrence of serious complication associated with LBBP procedure

To characterize occurrence of serious complication associated with LBBP procedure within 12 month post-implant.

Time frame: 12 months

QRS width between LBBP and CRT

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.

Time frame: 12 months

incidence and severity of tricuspid regurgitation

To assess and compare the incidence and severity of tricuspid regurgitation between LBBP and CRT treatment groups within 12 month post-implant

Time frame: 12 months

Central Contacts

Weijian Huang, MD

CONTACT

+86138-0669-1086 weijianhuang69@126.com

Lan Su, MD

CONTACT

+86 137-3874-2616 2512057600@qq.com

Data from ClinicalTrials.gov

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