Catheter Ablation vs Conservative Care in Elderly Patients With Atrial Fibrillation

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 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.

Conditions

• Atrial Fibrillation (AF)
• Atrial Fibrillation Ablation
• Elderly

Interventions

PROCEDURE

Catheter Ablation for Atrial Fibrillation

Catheter ablation for symptomatic atrial fibrillation with pulmonary vein isolation (PVI) prioritized as the primary lesion set. Energy source and tools are selected according to local practice and operator discretion (no restriction to a specific technology), performed under routine standards of care at experienced centres.

DRUG

Optimized Medical Therapy for Atrial Fibrillation

Guideline-directed rate and/or rhythm control tailored to the participant's clinical condition, including rate-control medications and/or antiarrhythmic drugs and cardioversion when clinically appropriate. AF ablation is not performed as part of this strategy.

DEVICE

Implantable Loop Recorder (ILR)

Subcutaneous implantable loop recorder used for continuous rhythm monitoring and quantification of atrial fibrillation burden throughout follow-up. Implanted in all participants according to protocol-defined workflow.

PROCEDURE

AV Node Ablation With Pacemaker implantation

AV node ablation with permanent pacing may be performed when clinically indicated according to routine care, as part of the optimized medical therapy strategy.

Sponsors & Collaborators

• University Hospital, Linkoeping

  collaborator OTHER

• Sahlgrenska University Hospital

  collaborator OTHER

• University Hospital, Umeå

  collaborator OTHER

• Dept of Cardiology, Örebro University Hospital, Sweden

  collaborator UNKNOWN

• Lund University Hospital

  collaborator OTHER

• Onassis Cardiac Surgery Centre

  collaborator OTHER

• Uppsala University Hospital

  collaborator OTHER

• University Hospital, Gentofte, Copenhagen

  collaborator OTHER

• Karolinska University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

78 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-20

Primary Completion

2031-11-01

Completion

2034-09-01

Countries

• Sweden

Study Locations