NCT05029570

Heart Rate Regularization in Atrial Fibrilation and Heart Failure

Conduction System PACing and Atrioventricular Node Ablation in Patients With hEart Failure, Left Ventricular Ejection Fraction >40% and Permanent Atrial FIBrilation: the PACE-FIB Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 334 (estimated)
• Sponsor: Daniel Rodríguez Muñoz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The PACE-FIB trial is a multicentre, randomised, open-label clinical trial. Patients older than 18 years, with permanent AF, LVEF\>40%, average resting heart rate ≤ 110 beats per minute (bpm), at least one hospitalisation due to HF in the previous year and basal NT-proBNP level\>900 pg/ml will be randomised to either CSP and subsequent AV node ablation (intervention group) vs. pharmacologic rate control optimised according to clinical practice guidelines. The impact of both strategies on a composite primary endpoint of all-cause mortality, HF hospitalisation and worsening HF will be evaluated during a 36-month follow-up.

Detailed description

Permanent atrial fibrillation (AF) causes beat-to-beat heart rate irregularity, which has shown to decrease cardiac output. Observational data suggest that heart rate regularization through atrioventricular (AV) node ablation and pacemaker implantation improves outcomes in heart failure (HF) patients. However, no trials have been conducted to assess its potential benefit in HF and left ventricular ejection fraction (LVEF)\>40%, a population in whom treatment strategies effectively improving outcomes are scarce. The goal of this trial is to assess the benefit of heart rate regularization through AV node ablation and conduction system pacing (CSP) in patients with permanent AF and HF with preserved or mildly reduced systolic function. The investigators hypothesize that heart rate regularization added to physiological pacing - preventing the deleterious effect of right apical pacing - reduces mortality, HF hospitalisations or worsening HF in these patients.

Conditions

• Heart Failure
• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Conduction System Pacing (pacemaker implantation)	Conduction System Pacing (pacemaker implantation) and Atrioventricular node ablation

Timeline

• Start date: 2022-04-29
• Primary completion: 2030-07-31
• Completion: 2030-09-01
• First posted: 2021-08-31
• Last updated: 2025-09-09

Locations

1 site across 1 country: Spain