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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Active, not recruiting

Conditions: Left Bundle Branch Pacing; Heart Failure

Treatments: Drug: GDMT; Device: LBBP+GDMT

Study type: Interventional

Funder types: Other

Identifiers

NCT06126081

2023-1996

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

LBBP+GDMT group

Experimental group

Description:

Patients in the LBBP+GDMT group will receive LBBP using dual-chamber device as priority and guideline-directed medical therapy. The pacing lead will be implanted at the left bundle branch and whether LBB is captured will be judged during the procedure. For patients who LBBP is failed, CRTP using triple-chamber device or LVSP by using dual-chamber device will be an alternative option according to the co-determination after consultation between doctors and patients .

Treatment:

Device: LBBP+GDMT

GDMT group

Active Comparator group

Description:

Patients in the GDMT group will receive guideline-directed medical therapy according to their complications, heart rate, blood pressure and so on. During follow-up of 6 months, patients may transfer to LBBP group if the LVEF decreased to \<35% and patients accepted the device implantation.

Treatment:

Drug: GDMT