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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Biventricular Pacing; Left Bundle Branch Area Pacing; Permanent Atrial Fibrillation; Heart Failure

Treatments: Device: Left bundle branch area pacing; Device: Biventricular pacing

Study type: Interventional

Funder types: Other

Identifiers

NCT05549544

2022-1704

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

LBBAP group

Experimental group

Description:

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.

Treatment:

Device: Left bundle branch area pacing

BiVP group

Active Comparator group

Description:

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.

Treatment:

Device: Biventricular pacing