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Recruiting NCT05029570

Heart Rate Regularization in Atrial Fibrilation and Heart Failure

No phase Interventional Heart Failure Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Conduction System Pacing (pacemaker implantation).
Who it may be relevant to
Registry conditions: Heart Failure, Atrial Fibrillation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed 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.

Interventions

  • Device Conduction System Pacing (pacemaker implantation)
    Conduction System Pacing (pacemaker implantation) and Atrioventricular node ablation

Primary outcome measures

  • Composite primary endpoint [Time frame: 36 months]
Secondary outcome measures (11)
  • All-cause mortality [Time frame: 36 months]
  • Cardiovascular mortality [Time frame: 36 months]
  • Heart failure hospitalization [Time frame: 36 months]
  • Worsening heart failure [Time frame: 36 months]
  • Unplanned cardiovascular hospitalisation [Time frame: 36 months]
  • Left ventricular ejection fraction [Time frame: 12 months]
  • Change in left ventricular dimension [Time frame: 12 months]
  • Change in degree of mitral regurgitation [Time frame: 12 months]
  • Change in functional status [Time frame: 36 months]
  • Major adverse events during or in the first 30-days following pacemaker implantation [Time frame: 30 days]
  • Major adverse events during or in the first 30-days following atrioventricular node ablation [Time frame: 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Hospital Universitario 12 de Octubre — Madrid

Identifiers

NCT: NCT05029570 · PACE-FIB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗