Catheter ABlation of Atrial fibrillation versus atrioventricular nodal ablation with CondUction System pacing in persistent atrial fibrillation and heart failure (ABACUS)
Persistent atrial fibrillation and heart failure
AF ablation is a routine procedure and may be performed according to the operator’s preference (e.g. radiofrequency ablation, cryoablation, pulsed-field ablation etc) but should include pulmonary vein isolation (PVI) and restoration of sinus rhythm as a goal. Patients may be included in the trial if they have had a single previous PVI, but any further redo procedures during the course of the trial are considered CVH endpoints. Rate and/or rhythm control medical therapy may be continued after the ablation procedure, as deemed necessary. Randomization will be 1:1 using RedCAP with the alternative intervention of CSP + AVNA. CSP implantation with His bundle pacing (HBP) or left bundle branch area pacing (LBBAP) is currently available in routine clinical practice and may be performed according to the operator’s preference but should include conduction system capture or left ventricular septal pacing (LVSP) as a goal. All hardware to be used are commercially available and some will soon receive regulatory approval for CSP. AVNA is a standard procedure which may be performed during the implantation or as a staged procedure, according to operator preference.
1. Persistent AF with symptomatic HF despite medical therapy, considered to be suitable for AF ablation, with at most one previous PVI procedure 2. At least one prior hospital admission, or emergency room / HF clinic visit for HF in the past 2 years, with NT-pro-BNP >1000 pg/ml or BNP >250 pg/ml measured at any timepoint during this interval 3. Previous or current rate or rhythm control drug therapy 4. Considered eligible for CSP implantation as an alternative to AF ablation 5. Age > or = 60 years
1. NYHA Class IV and systolic blood pressure ≤80 mmHg despite optimized therapy 2. Life expectancy <2 years 3. Need for major surgical intervention 4. Myocardial infarction, stroke or percutaneous coronary intervention within the previous 3 months 5. Previously implanted or planned implantation of CRT device or pacemaker. Implantable cardioverter defibrillator (ICD) implantation without a pacing indication is acceptable. 6. Participation in another controlled trial 7. Inability to sign an informed consent form