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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
334
Conduction System Pacing (pacemaker implantation) and Atrioventricular node ablation
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
RECRUITINGComposite primary endpoint
All-cause mortality, heart failure hospitalisation and worsening heart failure
Time frame: 36 months
All-cause mortality
Mortality due to any cause
Time frame: 36 months
Cardiovascular mortality
Mortality due to cardiovascular causes
Time frame: 36 months
Heart failure hospitalization
Hospitalization due to heart failure decompensation
Time frame: 36 months
Worsening heart failure
An episode of heart failure diagnosed based on symptoms, signs, imaging and analytical criteria that requires unplanned medical attention and intravenous diuretic therapy
Time frame: 36 months
Unplanned cardiovascular hospitalisation
Unplanned cardiovascular hospitalisation
Time frame: 36 months
Left ventricular ejection fraction
assessed by the Simpson method
Time frame: 12 months
Change in left ventricular dimension
end-diastolic and end-systolic volumes
Time frame: 12 months
Change in degree of mitral regurgitation
Change in degree of mitral regurgitation
Time frame: 12 months
Change in functional status
Assessed by New York Heart Association (NYHA) on a I to IV scale (I being better functional status and IV worst possible functional status)
Time frame: 36 months
Major adverse events during or in the first 30-days following pacemaker implantation
Percentage of patients suffering one of the following: death, cardiac tamponade, perforation requiring cardiac surgery, pneumothorax, haemothorax, device infection, endocarditis, lead displacement requiring re-intervention
Time frame: 30 days
Major adverse events during or in the first 30-days following atrioventricular node ablation
Percentage of patients suffering one of the following: death, cardiac tamponade, perforation requiring cardiac surgery, puncture site vascular complications requiring vascular surgery
Time frame: 30 days
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