Improving heart rate control in patients with atrial fibrillation 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
NA · Hospital Universitario 12 de Octubre · NCT05029570
This study is testing if a new heart treatment combining special pacing and a procedure can help people with atrial fibrillation and heart failure feel better compared to standard medication.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 334 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario 12 de Octubre (other) |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT05029570 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with permanent atrial fibrillation, a history of heart failure hospitalization, and specific heart function parameters.
Not a fit: Patients with severe frailty, acute heart failure, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival and quality of life for patients with heart failure and atrial fibrillation.
How similar studies have performed: While observational data suggest potential benefits of heart rate regularization, this specific approach has not been previously tested in this patient population.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Madrid, Madrid
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Atrial Fibrillation, atrial fibrillation, heart failure, conduction system pacing, heart rate regularization