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

N/AActive Not RecruitingNCT06126081

Fu Wai Hospital, Beijing, China36 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure Left Bundle Branch Pacing

Interventions

LBBP+GDMTDEVICE

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.

GDMTDRUG

GDMT is defined as the drug strategy for treatment of heart failure according to the current guidelines.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (2)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

The first affiliated hospital of Nanjing medical university

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

ΔLVEF between baseline and 6-month follow-up

ΔLVEF：change in LVEF in percentage (%) between baseline and 6-month follow-up

Time frame: 6 months

Secondary Outcomes

ΔLVEDD and ΔLVESV between baseline and 6-month follow-up

ΔLVEDD：change in LVEDD in millimeters between baseline and 6-month follow-up between two groups. ΔLVESV：change in LVESV in milliliters between baseline and 6-month follow-up between two groups.

Time frame: 6 months

The echocardiographic response rate of LVEF ≥50%

the percentage of patients with LVEF ≥50% at 6 month follow-up

Time frame: 6 months

The changes of NYHA function class between baseline and 6-month follow-up.

NYHA function class (from I to IV) is evaluated by clinicians at each outpatient follow-up visit;

Time frame: 6 months

Composite incidence rate of all-cause mortality and/or hospitalization for heart failure

All-cause death: including cardiovascular and non-cardiovascular deaths. Hospitalization for heart failure: an unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required medication therapy.

Time frame: 6 months

The rate of LVEF <=35% at six-month

The percentage of patients with LVEF \<=35% at 6 month follow-up

Time frame: 6 months

The changes of NT-proBNP between baseline and 6-month follow-up.

NT-proBNP in pg/ml was measured by performing a blood test;

Data from ClinicalTrials.gov

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