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Heart Rate Regularization in Atrial Fibrilation and Heart Failure

RecruitingNAAges 18 Years - anyAllDaniel Rodríguez Muñoz
NCT05029570 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Conduction System Pacing (pacemaker implantation)
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Where

1 site
Hospital Universitario 12 de Octubre
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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