Catheter ablation vs optimized medical care for very elderly with atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ACE-AF is a multicenter randomized trial evaluating catheter ablation against optimized medical therapy in adults 78 years and older with symptomatic AF. Participants are assigned 1:1 to ablation with standard rhythm-control strategies or to optimized medical therapy without ablation, with an implantable loop recorder continuously measuring AF burden. The trial uses contemporary ablation practices, prioritizing pulmonary vein isolation, and allows AV node ablation with pacemaker if clinically indicated. Randomization is stratified by sex and age group, and outcomes focus on rhythm and clinical endpoints while monitoring safety in an older population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Left atrial (LA) dimension \>55 mm, based on echocardiography within the previous year.
2. Acute coronary syndrome or coronary artery bypass surgery within the last 12 weeks.
3. Severe valvular heart disease (per ESC definitions) or congenital heart disease.
4. Prior surgical or catheter AF ablation procedure, or prior AV-node (atrioventricular nodal) ablation.
5. Contraindication to oral anticoagulation.
6. AF due to a reversible cause.
7. Medical condition likely to limit survival to \<12 months.
8. Unable or unwilling to provide informed consent.
9. History of non-compliance with medical therapy.
10. BMI \<18 or \>37 kg/m².

Where it's running

• Karolinska University Hospital
  Stockholm, Sweden Recruiting
• Linköping University Hospital
  Linköping, Sweden Not yet recruiting

Study contacts

• Principal investigator: Emmanouil Charitakis, MD, PhD — Karolinska University Hospital
• Study coordinator: Emmanouil Charitakis, MD, PhD
• Email: emmanouil.charitakis@regionstockholm.se
• Phone: 0046767877506

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.