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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Atrioventricular Block, Second and Third Degree; Left Bundle Branch Pacing
• Intervention / Treatment: Device: Left bundle branch pacing; Device: Bi-ventricular pacing

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weijian Huang, MD; Phone Number: +86138-0669-1086; Email: weijianhuang69@126.com

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • First Affliated Hospital, Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LBBP Treatment; Patients were performed left bundle branch pacing by a single/dual chamber pacemaker or dual chamber ICD device	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
Active Comparator: BVP Treatment; Patients were performed bi-ventricular pacing by a CRT/CRTD device	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of LVESV	To demonstrate and compare the LVESV at 12 month post-implant.	12 months
successful rate	To characterize the successful rate of LBBP Procedure and CRT Procedure among randomized patients' group.	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	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.	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.	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	12 months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Wenzhou Medical University
• Collaborators: Shanghai Zhongshan Hospital; Shanghai 10th People's Hospital; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Shanghai Chest Hospital; Sir Run Run Shaw Hospital; Chinese Academy of Medical Sciences, Fuwai Hospital; The Second Affiliated Hospital of Harbin Medical University; Second Affiliated Hospital of Nanchang University; The First Affiliated Hospital of Dalian Medical University; Tianjin Chest Hospital; Shanxi Cardiovascular Hospital; The First People's Hospital of Yunnan; Shenzhen Sun Yat-sen Cardiovascular Hospital; Yan'an Affiliated Hospital of Kunming Medical University; Xiamen Cardiovascular Hospital, Xiamen University; Medtronic (Shanghai) Management Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: heart failure; pacing induced cardiomyopathy; pacing; LBBP; BVP; RVP; conduction system pacing; cardiac Resynchronization Therapy; bradycardiac arrhythmia
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Block; Heart Failure; Atrioventricular Block
• Other Study ID Numbers: FirstWenzhouMU216-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No