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

NCT06126081 | Active Not Recruiting DMC

• 1 other identifier: 2023-1996
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Left Bundle Branch Pacing; Heart Failure

Keywords

Heart Failure; Left Bundle Branch Pacing; Guideline-Directed Medical Therapy

Outcome Measures

Primary Outcomes (1)

• ΔLVEF between baseline and 6-month follow-up

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

  6 months

Secondary Outcomes (8)

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

  6 months

• The echocardiographic response rate of LVEF ≥50%

  6 months

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

  6 months

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

  6 months

• The rate of LVEF <=35% at six-month

  6 months

Study Arms (2)

LBBP+GDMT group

EXPERIMENTAL

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 .

Device: LBBP+GDMT

GDMT group

ACTIVE COMPARATOR

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.

Drug: GDMT

Interventions

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.

Also known as: Early Resynchc

LBBP+GDMT group

GDMT DRUG

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

Also known as: Conventional treatment

GDMT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fu Wai Hospital, Beijing, China: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator

Study Sites (2)

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

Beijing, Beijing Municipality, 100037, China

Location

The first affiliated hospital of Nanjing medical university

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Xiaohan Fan, PhD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Model Details: 1:1 randomized to two groups

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: November 13, 2023
• Study Start: June 26, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)