About this trial
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 co-primary outcomes 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 SF-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.
Eligibility criteria
Qualifiers
Age ≥78 years.
ECG-documented atrial fibrillation.
AF type: paroxysmal, persistent, or longstanding persistent AF.
Suitable candidate for catheter ablation according to ESC guidelines.
Disqualifiers
Left atrial (LA) dimension >55 mm, based on echocardiography within the previous year.
Acute coronary syndrome or coronary artery bypass surgery within the last 12 weeks.
Severe valvular heart disease (per ESC definitions) or congenital heart disease.
Prior surgical or catheter AF ablation procedure, or prior AV-node (atrioventricular nodal) ablation.
Trial design
Treatments tested in this trial
- Catheter Ablation for Atrial Fibrillation
- Optimized Medical Therapy for Atrial Fibrillation
- Implantable Loop Recorder (ILR)
- AV Node Ablation With Pacemaker implantation
Treatment groups
Sponsors and collaborators
Karolinska University Hospital
Lead sponsor
University Hospital, Linkoeping
Collaborator
Sahlgrenska University Hospital
Collaborator
University Hospital, Umeå
Collaborator
Dept of Cardiology, Örebro University Hospital, Sweden
Collaborator
Lund University Hospital
Collaborator
Onassis Cardiac Surgery Centre
Collaborator
Uppsala University Hospital
Collaborator
University Hospital, Gentofte, Copenhagen
Collaborator