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

• Status: Recruiting
• Trial end date: 2025-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fu Wai Hospital, Beijing, China
• Collaborator: The First Affiliated Hospital with Nanjing Medical University

Criteria

Inclusion Criteria:

1. Age ≥ 18 years;

2. symptomatic heart failure despite guideline-directed medical therapy for at least 3 months, NYHA class II-IV, with an EF between 35% and 50%;

3. complete LBBB meeting Strauss's standard definition

4. Signed informed consent.

Exclusion Criteria:

1. Expected survival less than 24 months;

2. Indicated for ICD or pacing therapy;

3. History of VT, VF, or hemodynamic instability;

4. History of mechanical tricuspid valve replacement;

5. Ischemic cardiomyopathy scheduled for CABG and PCI within 3 months;

6. Severe structural heart disease may necessitate cardiac surgery or heart transplantation within 1 year;

7. Pregnancy or planning for pregnancy;

8. Hypertrophic cardiomyopathy or those underwent ventricular septal defect repair, in whom the success of LBBP is anticipated to be challenging;

9. Severe renal dysfunction (eGFR < 15ml/min*1.73m^2).