Clinical Efficacy of Left Bundle Branch Area Pacing for Patients With Permanent Atrial Fibrillation and Heart Failure (LBBAP-AFHF)

Clinical Efficacy of Left Bundle Branch Area Pacing for Patients With Permanent Atrial Fibrillation and Heart Failure ：A Multi-center Randomized Controlled Trial

This is a multicenter, randomized controlled study. This study aims to compare the clinical efficacy of LBBAP with traditional biventricular pacing in patients with permanent atrial fibrillation and heart Failure

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Left Bundle Branch Area Pacing; Permanent Atrial Fibrillation; Biventricular Pacing
• Intervention / Treatment: Device: Left bundle branch area pacing; Device: Biventricular pacing

Detailed Description

LBBAP-AFHF is a prospective, multicenter, randomized controlled trial that is designed to determine whether left bundle branch area pacing (LBBAP) may show superiority of improved LV function as compared with traditional biventricular pacing (BiVP) in patients with permanent atrial fibrillation and heart failure (LVEF<50%) who receive atrioventricular nodal ablation due to fast ventricular rate or require high percentage of ventricular pacing due to slow ventricular rate. The primary endpoint of this trial is the change in the LVEF at 6 months after device implantation from baseline. A CRT-P/D device would be implanted and LBBAP lead would be connected to the RA port and LV lead to the LV port. Patients who receive successful LBBAP and BiVP simultaneously during the procedure would be 1:1 randomized to LBBAP or BiVP group after the procedure by device programming. Patients will be followed at 3 and 6 months post-discharge for LVEF and other echographic parameters (including LVESV, response rate), and rehospitalization for heart failure or all-cause death.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haojie Zhu, M.D; Phone Number: +8613167310573; Email: 13167310573@163.com
• Study Contact Backup: Name: Xiaofei Li, M.D; Phone Number: +8617801013995; Email: lixiaofei0103@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Recruiting
      • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
      • Contact: Haojie Zhu; Phone Number: +8613167310573; Email: 13167310573@163.com
      • Contact: Xiaofei Li; Phone Number: +8617801013995; Email: lixiaofei0103@163.com
      • Principal Investigator: Xiaohan Fan
    • Beijing, Beijing, China, 100037
      • Not yet recruiting
      • Peking University First Hospital
      • Contact: Jing Zhou
  • Guangdong
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
      • Contact: Yangxin Chen
  • Hebei
    • Shijiazhuang, Hebei, China
      • Not yet recruiting
      • The Second Hospital of Hebei Medical University
      • Contact: Ruiqin Xie; Email: ruiqin_xie@sina.com
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Not yet recruiting
      • The First Affiliated Hospital of Nanjing Medical University
      • Contact: Jiangang Zou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients aged more than 18 years old
• Patients diagnosed with heart failure (LVEF<50%) and have received optimal medical therapy for at least 3 months

• Patients with permanent atrial fibrillation (QRS duration <130ms) which need ventricular pacing, including:

  1. LVEF<50%, NYHA II-IV, drug-refractory atrial fibrillation with the fast ventricular rate, planned atrioventricular nodal ablation due to 1). anticipated low success rate of atrial fibrillation catheter ablation or 2). patients refused to receive catheter ablation or 3). refused to receive another catheter ablation after a previous history of failed procedures
  2. LVEF<50%, NYHA II-IV, atrial fibrillation with slow ventricular rate, anticipated ventricular pacing burden ≥ 40%
• Written informed consent was provided

Exclusion Criteria:

• expected survival time is less than 12 months
• Prior history of mechanical tricuspid valve replacement and/or congenital heart disease (including dextrocardia, transposition of the great arteries, single left persistent left superior vena cava, etc.)
• Plan for PCI or CABG due to unstable angina or myocardial infarction in 3 months
• Surgery is required within 1 year due to severe structural heart disease
• Pregnancy, planned pregnancy or heart transplant
• Prior history of HCM and/or ventricular septal defect repair, who are unlikely to achieve successful LBBAP procedure.
• Failure of lead placement due to abnormal anatomy of the coronary sinus or enlarged right atrium, which makes it unable to switch from one pacing modality to another

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LBBAP group; Device: Left bundle branch area pacing(LBBAP) LBBAP is a novel physiological pacing form for ventricular pacing. In patients who received LBBAP, the pacing lead will be placed at the left bundle branch area to achieve a narrow-paced QRS duration.	Device: Left bundle branch area pacing; Left bundle branch area pacing is a novel physiological pacing modality and is reported to be feasible and safe in patients with heart failure and left bundle branch block.
Active Comparator: BiVP group; Device: Biventricular pacing (BiVP) Biventricular pacing is the traditional pacing modality for patients with heart failure. For BiVP, one pacing lead was placed in the coronary sinus, named LV lead, and another lead was placed in the right ventricule.	Device: Biventricular pacing; Biventricular pacing is a widely-established modality to treat heart failure in patients with heart failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ΔLVEF between baseline and six months post-discharge	ΔLVEF：change in LVEF between baseline and six months after procedure	Six months after device implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The immediate success rate of the LBBAP procedure	Successful LBBAP procedure is identified according to ECG and intracardiac ECG electrogram (IEGM) during the procedure. All LBBAP procedures will be categorized as selective left bundle branch pacing (S-LBBP), non-selective left bundle branch pacing(NS-LBBP), or left ventricular septal pacing (LVSP).	1 weeks
The rate of procedure and Device related complications	Procedure complications include pneumothorax, hemothorax, and air embolism. Device related complications include lead and pocket complications	6 months
ΔLVEDD between baseline and six months post-discharge	ΔLVEDD：change in LVEDD between baseline and six months after procedure between two groups	6 months
ΔLVEDV between baseline and six months post-discharge	ΔLVEDV：change in LVEDV between baseline and six months after procedure between two groups	6 months
The echocardiographic response rate of LVEF increase ≥5%	the percentage of patients with change of LVEF ≥5% at 6 month from baseline	6 months
The changes of NT-proBNP betwen baseline and 6 months post-discharge	The changes of NT-proBNP betwen baseline and 6 months post-discharge	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.	6 months
The echocardiographic response rate of LVEF increase ≥15%	an increase in LVESV ≥15% during follow-up at 6 month compared with baseline	6 months
The rate of ΔLVESV ≥15% between baseline and six months post-discharge	the percentage of patients with change of ΔLVESV ≥15% at 6 month from baseline	6 months

Collaborators and Investigators

• Sponsor: Fu Wai Hospital, Beijing, China
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Peking University First Hospital; The Second Hospital of Hebei Medical University; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Principal Investigator: Xiaohan Fan, PhD, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Heart Failure; Left Bundle Branch Area Pacing; Permanent Atrial Fibrillation; Biventricular Pacing
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Failure; Atrial Fibrillation
• Other Study ID Numbers: 2022-1704

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No