Catheter Ablation vs Conservative Care in Elderly Patients With Atrial Fibrillation (NCT07424690) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Catheter Ablation vs Conservative Care in Elderly Patients With Atrial Fibrillation
Sweden282 participantsStarted 2026-09-15
Plain-language summary
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.
Who can participate
Age range
78 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing catheter ablation directly against conservative care for older patients with atrial fibrillation — given my specific age and health situation, which of those two approaches does my doctor currently think is more appropriate for me, and why?
2The trial isn't recruiting yet, so if I were interested, how long might it realistically be before I could actually enroll, and what would my treatment options look like in the meantime?
3One of the main things this study is measuring is a combination of serious outcomes like stroke, heart failure hospitalization, and death — does my doctor think my current risk level for any of those events makes this kind of trial worth considering, or would standard treatment first be a safer path for me?
4The trial is also measuring quality of life using something called the RAND-36 General Health score — can my doctor explain what that means in practical terms, and how much might catheter ablation versus medication actually affect how I feel day to day at my age?
5Since this trial is listed as Phase NA and is specifically focused on elderly patients, what does my doctor know about how the risks of catheter ablation — like complications from the procedure itself — might be different for someone my age compared to younger AF patients?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.