Catheter Ablation vs Conservative Care in Elderly Patients With Atrial Fibrillation

Starting soon · Not applicable

Conditions studied: Atrial Fibrillation (AF), Atrial Fibrillation Ablation, Elderly

In brief

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.

Key facts

Study ID

NCT07424690

Run by

Karolinska University Hospital

People needed

282

Starts

2026-09-15

Expected to finish

2034-09-15

Last updated by the study team

2026-08-05

Who can join

Age: 78 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥78 years.
• ECG-documented atrial fibrillation.
• AF type: paroxysmal, persistent, or longstanding persistent AF.
• Suitable candidate for catheter ablation according to ESC guidelines.
• Charlson's comorbidity index ≤7.

You may not qualify if…

• 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.
• Contraindication to oral anticoagulation.
• AF due to a reversible cause.
• Medical condition likely to limit survival to <12 months.
• Unable or unwilling to provide informed consent.
• History of non-compliance with medical therapy.
• BMI <18 or >37 kg/m².

Where it is running

• Karolinska University Hospital — Stockholm, Sweden

Full record on ClinicalTrials.gov

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