Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sociedad Castellana de Cardiologia | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conduction System Pacing and AV node ablation | Experimental | Atrioventricular node ablation and subsequent conduction system pacing |
|
| Medical treatment for rate control of AF | No Intervention | Pharmacological rate control based on clinical practice guidelines |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conduction System Pacing (pacemaker implantation) | Device | Conduction System Pacing (pacemaker implantation) and Atrioventricular node ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite primary endpoint | All-cause mortality, heart failure hospitalisation and worsening heart failure | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Mortality due to any cause | 36 months |
| Cardiovascular mortality | Mortality due to cardiovascular causes | 36 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Rodriguez Muñoz, MD, PhD | Contact | +34 917792742 | danielantonio.rodriguez@salud.madrid.org | |
| Ana Isabel Castillo Varón, PhD | Contact | +34 917792742 | aicastillo.imas12@h12o.es |
| Name | Affiliation | Role |
|---|---|---|
| Fernando Arribas Ynsaurriaga, MD, PhD | Hospital Universitario 12 de Octubre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | Madrid | 28041 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
Not provided
Not provided
Medical Device: Conduction System Pacing (pacemaker implantation)
Not provided
Not provided
Clinical outcomes will be adjudicated by the investigator and reviewed by the Clinical Events Committee, that will be blind to treatment received by the patient.
|
| Heart failure hospitalization | Hospitalization due to heart failure decompensation | 36 months |
| Worsening heart failure | An episode of heart failure diagnosed based on symptoms, signs, imaging and analytical criteria that requires unplanned medical attention and intravenous diuretic therapy | 36 months |
| Unplanned cardiovascular hospitalisation | Unplanned cardiovascular hospitalisation | 36 months |
| Left ventricular ejection fraction | assessed by the Simpson method | 12 months |
| Change in left ventricular dimension | end-diastolic and end-systolic volumes | 12 months |
| Change in degree of mitral regurgitation | Change in degree of mitral regurgitation | 12 months |
| Change in functional status | Assessed by New York Heart Association (NYHA) on a I to IV scale (I being better functional status and IV worst possible functional status) | 36 months |
| Major adverse events during or in the first 30-days following pacemaker implantation | Percentage of patients suffering one of the following: death, cardiac tamponade, perforation requiring cardiac surgery, pneumothorax, haemothorax, device infection, endocarditis, lead displacement requiring re-intervention | 30 days |
| Major adverse events during or in the first 30-days following atrioventricular node ablation | Percentage of patients suffering one of the following: death, cardiac tamponade, perforation requiring cardiac surgery, puncture site vascular complications requiring vascular surgery | 30 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |