Conduction system pacing and atrioventricular node ablation in heart failure: The PACE-FIB study design

Area of Science:

• Cardiology
• Electrophysiology
• Heart Failure Research

Background:

• Atrial fibrillation (AF) negatively impacts prognosis in heart failure (HF) patients.
• Effective treatments are limited for permanent AF in heart failure with preserved ejection fraction (HFpEF) or mildly reduced ejection fraction (HFmrEF).

Purpose of the Study:

• To evaluate the long-term benefits and safety of heart rate regularization using left-bundle branch pacing (LBBP) and atrioventricular node ablation (AVNA).
• To compare the LBBP-AVNA strategy against standard pharmacological rate control in HFpEF/HFmrEF patients with permanent AF.

Main Methods:

• The PACE-FIB trial is a prospective, multicentre, open-label, randomized study (1:1 ratio).
• 334 patients with HFpEF/HFmrEF and permanent AF will be randomized to either LBBP followed by AVNA or optimal pharmacological rate control.
• Follow-up duration is a minimum of 36 months, with a composite primary outcome of all-cause mortality, HF hospitalization, and worsening HF.

Main Results:

• The study is ongoing, with recruitment between March 2022 and February 2027.
• Primary outcome data at 36 months will assess the composite endpoint.
• Secondary outcomes include echocardiographic parameters, functional status, and adverse events.

Conclusions:

• Left-bundle branch pacing (LBBP) presents a promising approach for heart rate regularization.
• The pace-and-ablate strategy (LBBP + AVNA) may offer clinical benefits over pharmacological rate control in this patient population.
• This is the first randomized trial to investigate the long-term efficacy and safety of LBBP-AVNA in HFpEF/HFmrEF with permanent AF.