Catheter Ablation vs Conservative Care in Elderly Patients With Atrial Fibrillation

ACE-AF is a multicenter randomized study in people aged 78 years and older with symptomatic atrial fibrillation (AF). AF is a common heart rhythm disorder in older adults and can cause reduced quality of life and lead to serious complications such as stroke and heart failure. The study compares two established treatment strategies: 1. Catheter ablation (an invasive procedure aimed at reducing AF by electrically isolating triggers in the heart, primarily through pulmonary vein isolation), and 2. Optimized medical therapy without AF ablation (medications for rate and/or rhythm control; AV node ablation with pacemaker may be used if clinically indicated according to routine care). Participants are randomized 1:1 to one of these strategies. All participants will receive an implantable loop recorder (a small heart rhythm monitor placed under the skin) to continuously track heart rhythm and measure AF burden over time. The study has two primary endpoints, tested with Holm-Bonferroni multiplicity control assessed over 24 months: 1. a composite of major clinical events (all-cause mortality, stroke, major bleeding, cardiac arrest, or hospitalization due to heart failure), and 2. patient-reported health-related quality of life (HRQoL), measured by the RAND-36 "General Health" domain. ACE-AF will provide evidence to guide treatment decisions for very elderly patients with symptomatic AF and help identify which patients benefit most from an ablation-based strategy compared with optimized medical therapy.

NCT Number	NCT07424690
Lead Sponsor	Karolinska University Hospital Collaborators: University Hospital, Linkoeping, Sahlgrenska University Hospital, University Hospital, Umeå, Dept of Cardiology, Örebro University Hospital, Sweden, Lund University Hospital, Onassis Cardiac Surgery Centre, Uppsala University Hospital, Royal Adelaide Hospital
Conditions	Atrial Fibrillation (AF), Atrial Fibrillation Ablation, Elderly
Enrollment	282 participants
Start Date	2026-09-15
Primary Completion	2031-12-15 (estimated)
Study Completion	2034-09-15 (estimated)
Updated on ClinicalTrials.gov	2026-08-05