NCT07424690Recruiting
Catheter Ablation vs Conservative Care in Elderly Patients With Atrial Fibrillation
Assessment of the Effect of Catheter Ablation on Elderly Population With Atrial Fibrillation; a Randomized Controlled Study; The ACE-AF Study
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 282 (estimated)
- First submitted
- 5 Feb 2026
- Start date
- 5 Oct 2026
- Primary completion date
- 15 Dec 2031
- Lead sponsor
- Karolinska University Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT07424690
What you commit to
- Study type: Interventional
- Planned participants: 282
- From 5 Oct 2026 to the primary completion date, 15 Dec 2031
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Left atrial (LA) dimension \>55 mm, based on echocardiography within the previous year.
- Prior surgical or catheter AF ablation procedure, or prior AV-node (atrioventricular nodal) ablation.
Other illness
- Acute coronary syndrome or coronary artery bypass surgery within the last 12 weeks.
- Severe valvular heart disease (per ESC definitions) or congenital heart disease.
- Medical condition likely to limit survival to \<12 months.
- History of non-compliance with medical therapy.
Other
- Contraindication to oral anticoagulation.
- AF due to a reversible cause.
- Unable or unwilling to provide informed consent.
- BMI \<18 or \>37 kg/m².
Who the study is looking for
- 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.
Age in the registry: 78 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Linkoping University Hospital Coordinator of this site? Confirm its status | Linköping | Sweden | Not yet recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.