Heart Rate Regularization in Atrial Fibrilation and Heart Failure (PACE-FIB)

Daniel Rodríguez Muñoz

Status

Enrolling

Conditions

Atrial Fibrillation

Heart Failure

Treatments

Device: Conduction System Pacing (pacemaker implantation)

Study type

Interventional

Funder types

Other

Identifiers

NCT05029570

PACE-FIB

Details and patient eligibility

About

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.

Full 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.

Enrollment

334 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Permanent atrial fibrillation
At least one episode of hospitalisation due to heart failure in the previous 12 months.
Left ventricular ejection fraction > 40%
Average resting heart rate ≤ 110 beats per minute
NT-proBNP ≥ 900 pg/ml in the 30 days prior to enrollment
Age ≥ 18 years
Capacity to understand the nature of the study, legal ability and willingness to give informed consent.

Exclusion criteria

Severe frailty (Clinical Frailty Scale ≥ 7) or comorbidity reducing life expectancy to < 12 months.
Acute heart failure at the time of enrollment or systolic blood pressure < 80 mmHg in the absence of inotropic agents.
Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 20 ml/1,73 m2
Severe mitral or aortic valvular heart disease
Anaemia (Haemoglobin < 10 g/dl)
Morbid obesity (BMI ≥ 35)
Severe Chronic Obstructive Pulmonary Disease (Gold ≥ 3)
Presence of a different indication for pacing of implantable cardioverter-defibrillator (ICD)
Obstructive hypertrophic cardiomyopathy
Infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others)
Simultaneous participation in a different trial