Left Bundle Branch Pacing (LBBP) for the Treatment of Cardiac Dysfunction With Safety and Efficacy Study in Patients With Atrioventricular Block

This study periodically assessed patients' cardiac function and prognosis by cardiac ultrasound, NYHA cardiac function class, 6-minute walk distance, quality of life score (QoL), and clinical events at follow-up, with the aim of assessing whether LBBP is no less effective than CRT in patients with left ventricular ejection fraction (LVEF) <50% and estimated percentage of ventricular pacing >40% of cardiac dysfunction.

Study Overview

• Status: Not yet recruiting
• Conditions: Consented to Participate in the Trial and Signed an Informed Consent Form; NYHA Heart Function Classification of I-III
• Intervention / Treatment: Device: LBBP/CRT

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

• Study Contact: Name: Chen Keping, Doctor; Phone Number: +86 13811266140; Email: chenkepingfw@126.com
• Study Contact Backup: Name: Li Jie, Bachelor; Phone Number: +86 13811266140; Email: lijie_mmtchina@163.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Patients with cardiac dysfunction

Description

Inclusion Criteria:

• Be at least 18 years of age.
• Consent to participate in the trial and have signed an informed consent form.
• NYHA cardiac function classification of I-III.
• LVEF < 50%.
• Ventricular pacing-dependent patients with second-degree or complete AV block with pacing indications or ventricular pacing percentage >40%.
• Patients who are willing to implant a new implant or have their device replaced or upgraded.

Exclusion Criteria:

• Life expectancy <1 year.
• Patients with severe tricuspid valve disease1 or who have undergone mechanical or bioprosthetic valve surgery.
• have had an acute myocardial infarction within 1 month
• Women of childbearing potential who are pregnant or who become pregnant during the study period.
• Severe hepatic or renal dysfunction.
• Have been enrolled in other clinical studies that may interfere with the objectives of this trial.
• Have evidence of severe pulmonary hypertension (PASP > 70 mmHg).
• Have evidence of hypertrophic cardiomyopathy that would affect the patient's prognosis.
• Subjects who, in the opinion of the investigator, are physically unfit to participate in this trial.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LBBP	Device: LBBP/CRT; The trial plans to enroll 160 patients with cardiac dysfunction who meet the enrollment criteria and agree to participate in the trial, and randomly assign them to the LBBP and CRT groups in a 1:1 ratio
CRT	Device: LBBP/CRT; The trial plans to enroll 160 patients with cardiac dysfunction who meet the enrollment criteria and agree to participate in the trial, and randomly assign them to the LBBP and CRT groups in a 1:1 ratio

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12 months of LVEF	LVEF at 12 months after implantation was analyzed to compare the LBBP treatment group with the CRT treatment group for the target subjects.	12 months

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 20, 2023
• Primary Completion (Anticipated): March 20, 2025
• Study Completion (Anticipated): March 20, 2025

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Block; Atrioventricular Block
• Other Study ID Numbers: 20230320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a multicenter, prospective, randomized controlled trial. The trial plans to enroll 160 patients with cardiac dysfunction who meet the enrollment criteria and agree to participate in the trial, and randomly assign them to the LBBP and CRT groups in a 1:1 ratio. Patients who are successfully implanted will be enrolled for evaluation and follow-up.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No