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NCT Number: NCT06126081

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years;
  • symptomatic heart failure despite guideline-directed medical therapy for at least 3 months, NYHA class II-IV, with an EF between 35% and 50%;
  • complete LBBB meeting Strauss's standard definition
  • Signed informed consent.

Exclusion criteria

  • Expected survival less than 24 months;
  • Indicated for ICD or pacing therapy;
  • History of VT, VF, or hemodynamic instability;
  • History of mechanical tricuspid valve replacement;
  • Ischemic cardiomyopathy scheduled for CABG and PCI within 3 months;
  • Severe structural heart disease may necessitate cardiac surgery or heart transplantation within 1 year;
  • Pregnancy or planning for pregnancy;
  • Hypertrophic cardiomyopathy or those underwent ventricular septal defect repair, in whom the success of LBBP is anticipated to be challenging;
  • Severe renal dysfunction (eGFR < 15ml/min*1.73m^2).

Treatment and study plan

LBBP+GDMT

Device

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.

Other names: Early Resynchc

GDMT

Drug

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

Other names: Conventional treatment

Primary outcomes

  1. ΔLVEF between baseline and 6-month follow-up

    Time frame: 6 months

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

Secondary outcomes

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

    Time frame: 6 months

    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.

  2. The echocardiographic response rate of LVEF ≥50%

    Time frame: 6 months

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

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

    Time frame: 6 months

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

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

    Time frame: 6 months

    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.

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

    Time frame: 6 months

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

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

    Time frame: 6 months

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

  7. The changes of 6MWD between baseline and 6-month follow-up.

    Time frame: 6 months

    6MWD in meters stands for "6-Minute Walk Distance." It is a common test used to assess a person's functional exercise capacity and cardiovascular endurance. During the test, the patient is asked to walk as far as possible within a span of 6 minutes in a straight path or designated walking course;

  8. The changes of QoL between baseline and 6-month follow-up.

    Time frame: 6 months

    QoL stands for "Quality of Life", which is measured by The Minnesota Living with Heart Failure Questionnaire (MLHFQ). The MLHFQ is a self-administered disease-specific questionnaire for patients with HF, comprising 21 items from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL).

Sponsors and collaborators

Lead sponsor

Fu Wai Hospital, Beijing, China

Other

Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

Registry information

Official study 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.

Acronym: Early-RESYNC

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 13, 2023
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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