Key result
PACE-FIB tests LBBP plus AV ablation versus rate control in HFpEF/HFmrEF with permanent AF.
Why the study?
AF worsens prognosis in HF, and successful treatments are scarce for patients with permanent AF and HFpEF or HFmrEF.
Does left-bundle branch pacing followed by atrioventricular node ablation reduce the composite of all-cause mortality, HF hospitalization, and worsening HF in patients with HFpEF/HFmrEF and permanent AF compared to pharmacological rate control?
RCT (n=334)
Open-label
1:1
Yes
Does left-bundle branch pacing followed by atrioventricular node ablation reduce the composite of all-cause mortality, HF hospitalization, and worsening HF in patients with HFpEF/HFmrEF and permanent AF compared to pharmacological rate control?
The PACE-FIB trial will evaluate whether a pace-and-ablate strategy using left-bundle branch pacing improves clinical outcomes compared to pharmacological rate control in patients with HFpEF/HFmrEF and permanent AF.
AIMS: Atrial fibrillation (AF) worsens the prognosis of patients with heart failure (HF). Successful treatments are still very scarce for those with permanent AF and preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction. In this study, the long-term benefits and safety profile of heart rate regularization through left-bundle branch pacing (LBBP) and atrioventricular node ablation (AVNA) will be explored in comparison with pharmacological rate-control strategy. METHODS AND RESULTS: The PACE-FIB trial is a multicentre, prospective, open-label, randomized (1:1) clinical study that will take place between March 2022 and February 2027. A total of 334 patients with HFpEF/HFmrEF and permanent AF will receive either LBBP followed by AVNA (intervention arm) or optimal pharmacological treatment for heart rate control according to European guideline recommendations (control arm). All patients will be followed up for a minimum of 36 months. The primary outcome measure will be the composite of all-cause mortality, HF hospitalization, and worsening HF at 36 months. Other secondary efficacy and safety outcome measures such as echocardiographic parameters, functional status, and treatment-related adverse events, among others, will be analysed too. CONCLUSION: LBBP is a promising stimulation mode that may foster the clinical benefit of heart rate regularization through AV node ablation compared with pharmacological rate control. This is the first randomized trial specifically addressing the long-term efficacy and safety of this pace-and-ablate strategy in patients with HFpEF/HFmrEF and permanent AF.
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Muñoz et al. (2023) conducted an RCT in Heart failure with preserved or mildly reduced ejection fraction and permanent atrial fibrillation (n=334). Left-bundle branch pacing (LBBP) followed by atrioventricular node ablation (AVNA) vs. Optimal pharmacological treatment for heart rate control was evaluated on Composite of all-cause mortality, HF hospitalization, and worsening HF at 36 months. The PACE-FIB trial will randomize 334 patients with HFpEF/HFmrEF and permanent AF to left-bundle branch pacing followed by AV node ablation versus pharmacological rate control.
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