Catheter Ablation vs Conservative Care in Elderly Patients With Atrial Fibrillation

NCT07424690 | Not Yet Recruiting DMC

• 1 other identifier: 2025-02305-01
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

Brief 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. 1.Catheter ablation (an invasive procedure aimed at reducing AF by electrically isolating triggers in the heart, primarily through pulmonary vein isolation), and
2. 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).
3. 3.a composite of major clinical events (all-cause mortality, stroke, major bleeding, cardiac arrest, or hospitalization due to heart failure), and
4. 4.patient-reported health-related quality of life (HRQoL), measured by the SF-36 "General Health" domain.

Conditions

Atrial Fibrillation (AF); Atrial Fibrillation Ablation; Elderly

Keywords

atrial fibrillation; catheter ablation; rhtyhm control; rate control; implantable loop recorder; elderly; Health-related quality of life; Randomized controlled study

Outcome Measures

Primary Outcomes (2)

• Composite clinical endpoint (all-cause mortality, stroke, serious bleeding, cardiac arrest, or heart failure hospitalization)

  First part of the co-primary outcome: Proportion of participants with ≥1 of the following events within 24 months after intervention (visit 2): all-cause death, stroke, serious bleeding, cardiac arrest, or hospitalization for heart failure. Events will be adjudicated per protocol.

  24 months after intervention (visit 2)

• Change in RAND-36 General Health score

  Second part of the co-primary outcome: Change from baseline in the RAND-36 "General Health" domain score at 24 months after the intervention (visit 2). Scores range 0-100; higher scores indicate better perceived health.

  Baseline to 24 months after intervention (visit 2)

Secondary Outcomes (13)

• Differences of atrial fibrillation and atrial tachycardia burden (ILR-derived) between groups

  From date of ILR implantation (intervention day, visit 2) up to 30 months after implantation.

• Hospitalizations (all-cause and cardiovascular)

  Up to 24 months after intervention

• Serious adverse events and treatment-related complications

  Up to 24 months after intervention

• Additional patient-reported outcomes (AF symptoms / disease-specific HRQoL)

  Baseline and follow-up (3, 12, 18) through 24 months after intervention

• Changes in Left atrial reservoir strain (LASr)

  Up to 12 months after intervention (visit 2)

Other Outcomes (4)

• Discrimination of an inflammation proteomics-based prediction model for the ACE-AF primary composite outcome

  Up to 24 months after intervention (visit 2).

• Correlation between change in Epicardial fat and the combined AF/AT burden

  From implantation (visit 2) up to 24 months after the intervention

• Discrimination of a saliva proteomics-based prediction model for the primary composite outcome

  Baseline through 24 months after intervention

Study Arms (2)

Catheter Ablation Strategy

ACTIVE COMPARATOR

Participants randomized to this arm will undergo catheter ablation for atrial fibrillation, with pulmonary vein isolation (PVI) prioritized as the primary ablation strategy. Energy source and tools are selected according to local practice and operator discretion (no restriction to a specific technology). Participants will also receive an implantable loop recorder (ILR) for continuous rhythm monitoring throughout follow-up. Additional medical therapy may be used as clinically indicated according to guideline-based care.

Procedure: Catheter Ablation for Atrial Fibrillation; Drug: Optimized Medical Therapy for Atrial Fibrillation; Device: Implantable Loop Recorder (ILR)

Optimized Medical Therapy (Rate/Rhythm control) ± AV Node Ablation + Pacing + ILR

ACTIVE COMPARATOR

Participants randomized to this arm will receive optimized guideline-directed medical therapy for atrial fibrillation without AF catheter ablation. Treatment may include rate control and/or rhythm control (including antiarrhythmic drugs and/or cardioversion when clinically appropriate). AV node ablation with pacemaker implantation is permitted when clinically indicated according to routine care. Participants will also receive an implantable loop recorder (ILR) for continuous rhythm monitoring throughout follow-up.

Drug: Optimized Medical Therapy for Atrial Fibrillation; Procedure: AV Node Ablation With Pacemaker implantation

Interventions

Catheter Ablation for Atrial Fibrillation PROCEDURE

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.

Also known as: catheter ablation, pulmonary vein isolation

Catheter Ablation Strategy

Optimized Medical Therapy for Atrial Fibrillation DRUG

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.

Also known as: Guideline-directed medical therapy, Rate control, Rhythm control

Catheter Ablation Strategy; Optimized Medical Therapy (Rate/Rhythm control) ± AV Node Ablation + Pacing + ILR

Implantable Loop Recorder (ILR) DEVICE

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.

Catheter Ablation Strategy

AV Node Ablation With Pacemaker implantation PROCEDURE

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

Optimized Medical Therapy (Rate/Rhythm control) ± AV Node Ablation + Pacing + ILR

Eligibility Criteria

• Age: 78 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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.

Sponsors & Collaborators

• Karolinska University Hospital: lead
• University Hospital, Linkoeping: collaborator
• Sahlgrenska University Hospital: collaborator
• University Hospital, Umeå: collaborator
• Dept of Cardiology, Örebro University Hospital, Sweden: collaborator
• Lund University Hospital: collaborator
• Onassis Cardiac Surgery Centre: collaborator
• Uppsala University Hospital: collaborator
• University Hospital, Gentofte, Copenhagen: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (14)

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MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation; Heart Rate

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Emmanouil Charitakis, MD, PhD

CONTACT

0046767877506; emmanouil.charitakis@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label due to the nature of the interventions (catheter ablation vs optimized medical therapy). Endpoint definitions and event documentation are standardized per protocol.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Investigator-initiated, multicenter, parallel-group randomized controlled trial with 1:1 allocation to two management strategies (catheter ablation vs optimized medical therapy). Open-label due to the nature of the interventions; follow-up through 24 months with continuous ILR monitoring in both arms.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 20, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): November 1, 2031
• Study Completion (Estimated): September 1, 2034
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

SE (1)