Improving heart rate control in patients with atrial fibrillation and heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PACE-FIB trial is a multicenter, randomized, open-label clinical trial designed to evaluate the effectiveness of conduction system pacing (CSP) combined with AV node ablation compared to standard pharmacologic rate control in patients with permanent atrial fibrillation and heart failure. Participants will be randomized to receive either the intervention or standard care, and their outcomes will be monitored over a 36-month period. The primary endpoint includes all-cause mortality, heart failure hospitalizations, and worsening heart failure. This trial aims to address the lack of effective treatment strategies for patients with preserved or mildly reduced left ventricular ejection fraction.

Why it matters

Who can join: the full rules

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

Where it's running

• Hospital Universitario 12 de Octubre
  Madrid, Madrid, Spain Recruiting

Study contacts

• Study coordinator: Daniel Rodriguez Muñoz, MD, PhD
• Email: danielantonio.rodriguez@salud.madrid.org
• Phone: +34 917792742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.