Pacemaker Pacing Compared With Drug Heart Rate Control in Atrial Fibrillation and Heart Failure
Tests a pacemaker-based heart rhythm treatment in adults with heart failure and permanent atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Heart Rate Regularization in Atrial Fibrilation and Heart Failure
Key facts
- Where
- Madrid, SpainSee the site
Where in Spain
- Hospital Universitario 12 de OctubreMadrid, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Daniel Rodríguez Muñoz
- Trial code
- NCT05029570
- Record updated
- 9 September 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; Severe Chronic Obstructive Pulmonary Disease (Gold ≥ 3); Infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others); Anaemia (Haemoglobin < 10 g/dl); Severe frailty (Clinical Frailty Scale ≥ 7) or comorbidity reducing life expectancy to < 12 months; Morbid obesity (BMI ≥ 35); Presence of a different indication for pacing of implantable cardioverter-defibrillator (ICD); Obstructive hypertrophic cardiomyopathy; Simultaneous participation in a different trial.