Clinical Efficacy of Early Left Bundle Branch Pacing for Cardiac Resynchronization Therapy — Early-RESYNC  

Heart Failure Clinical Trial

Official title: Clinical Efficacy of Early Left Bundle Branch Pacing for Cardiac Resynchronization Therapy Compared With Guideline-directed Medical Therapy in Heart Failure With Mild-reduced Ejection Fraction.

Status Recruiting

Clinical Trial Summary

This is a two-center, prospective randomized controlled trial. The aim of this study is to compare the clinical efficacy of early left bundle branch pacing for cardiac resynchronization therapy and guideline-directed medical therapy in heart failure with mild-reduced ejection fraction.

Clinical Trial Description

Early-resync is a two-center, prospective randomized controlled trial that is designed to determine whether early left bundle branch pacing has a better impact on LV function improvement as compared with traditional guideline-directed medical therapy in heart failure with mild-reduced ejection fraction（36%≤LVEF≤50%） and complete left bundle branch block (CLBBB). Patients with symptomatic heart failure,36%≤LVEF≤50%, NYHA function class II-IV, and CLBBB（according to STRAUSS criteria) will be 1:1 randomized to LBBP+GDMT or GDMT group after enrollment and be followed at 3 and 6 months after randomization. LBBP will be performed by a double-chamber device in LBBP+GDMT group. All patients will receive GDMT. The primary endpoint is the change in the LVEF at 6 months after randomization from baseline. ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT06126081
• Study type: Interventional
• Source: Fu Wai Hospital, Beijing, China
• Contact: Chen He, M.D
• Phone: +8618059707043
• Email: 18059707043@163.com
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2023
• Completion date: December 30, 2025