Clinical Efficacy of Left Bundle Branch Area Pacing for Patients With Permanent Atrial Fibrillation and Heart Failure

Not Applicable

Recruiting

• Conditions: Permanent Atrial Fibrillation; Left Bundle Branch Area Pacing; Heart Failure; Biventricular Pacing
• Interventions: Device: Left bundle branch area pacing; Device: Biventricular pacing

• Registration Number: NCT05549544
• Lead Sponsor: Fu Wai Hospital, Beijing, China

Brief Summary

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

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 Timeline

• Study Start: 2022-07-18
• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-22
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-10
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LBBAP group	Left bundle branch area pacing	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.
BiVP group	Biventricular pacing	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.

Primary Outcome Measures

Name	Time	Method
ΔLVEF between baseline and six months post-discharge	Six months after device implantation	ΔLVEF：change in LVEF between baseline and six months after procedure

Secondary Outcome Measures

Name	Time	Method
ΔLVEDV between baseline and six months post-discharge	6 months	ΔLVEDV：change in LVEDV between baseline and six months after procedure between two groups
The echocardiographic response rate of LVEF increase ≥5%	6 months	the percentage of patients with change of LVEF ≥5% at 6 month from baseline
The changes of NT-proBNP betwen baseline and 6 months post-discharge	6 months	The changes of NT-proBNP betwen baseline and 6 months post-discharge
The rate of ΔLVESV ≥15% between baseline and six months post-discharge	6 months	the percentage of patients with change of ΔLVESV ≥15% at 6 month from baseline
ΔLVEDD between baseline and six months post-discharge	6 months	ΔLVEDD：change in LVEDD between baseline and six months after procedure between two groups
The echocardiographic response rate of LVEF increase ≥15%	6 months	an increase in LVESV ≥15% during follow-up at 6 month compared with baseline
The immediate success rate of the LBBAP procedure	1 weeks	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).
The rate of procedure and Device related complications	6 months	Procedure complications include pneumothorax, hemothorax, and air embolism. Device related complications include lead and pocket complications
Composite incidence rate of all-cause mortality and/or hospitalization for heart failure	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.

Trial Locations

Locations (5)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

The first affiliated hospital of Nanjing medical university; 🇨🇳 Nanjing, Jiangsu, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

The Second Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China