NCT06126081

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

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: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Fu Wai Hospital, Beijing, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Heart Failure
• Left Bundle Branch Pacing

Interventions

Type	Name	Description
DEVICE	LBBP+GDMT	LBBP is a procedure that the pacing lead is placed at the left bundle branch to achieve electrical and mechanical synchronization by pacing the left bundle branch area with stable pacing parameters.
DRUG	GDMT	GDMT is defined as the drug strategy for treatment of heart failure according to the current guidelines.

Timeline

• Start date: 2023-06-26
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-11-13
• Last updated: 2026-03-31

Locations

2 sites across 1 country: China