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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05553626
• Other study ID #: FirstWenzhouMU216-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: February 2025

Study information

• Verified date: July 2022
• Source: First Affiliated Hospital of Wenzhou Medical University
• Contact: Weijian Huang, MD
• Phone: +86138-0669-1086
• Email: weijianhuang69[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: February 2025
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrioventricular Block
• Heart Failure

Intervention

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
• Bi-ventricular pacing
Bi-ventricular pacing by a CRT/CRTD device

Locations

Country	Name	City	State
China	First Affliated Hospital, Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (17)

Lead Sponsor

Collaborator

First Affiliated Hospital of Wenzhou Medical University

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of LVESV	To demonstrate and compare the LVESV at 12 month post-implant.	12 months
Secondary	successful rate	To characterize the successful rate of LBBP Procedure and CRT Procedure among randomized patients' group.	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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