NCT05029570Recruiting
Heart Rate Regularization in Atrial Fibrilation and Heart Failure
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
Source: ClinicalTrials.gov · Last updated 9 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 334 (estimated)
- First submitted
- 26 Aug 2021
- Start date
- 29 Apr 2022
- Primary completion date
- 31 Jul 2030
- Lead sponsor
- Daniel Rodríguez Muñoz
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT05029570
What you commit to
- Study type: Interventional
- Planned participants: 334
- From 29 Apr 2022 to the primary completion date, 31 Jul 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Lab values
- Anaemia (Haemoglobin \< 10 g/dl)
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.