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Sex specific differences in outcomes following atrial fibrillation (AF) ablation versus medical therapy in patients with AF and heart failure

Evaluating QUantitative differences in women versus men with Atrial Fibrillation and Heart FaiLure undergoing AF ablation - The EQUAL-AF study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000500358
Acronym
EQUAL-AF study
Enrollment
240
Registered
2026-04-22
Start date
2026-04-27
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The EQUAL-AF study is a randomized clinical trial designed to investigate whether treatment outcomes for atrial fibrillation differ between women and men. The study compares catheter ablation for rhythm control versus guideline-directed medical therapy in patients with atrial fibrillation and heart failure. Although catheter ablation has shown benefits in previous trials, women have been underrepresented, leaving uncertainty about whether treatment effects are similar across sexes. EQUAL-AF therefore randomizes women and men separately to evaluate treatment response within each sex and to assess whether outcomes differ between them. The study aims to generate evidence to guide more equitable and personalized treatment strategies for patients with atrial fibrillation.

Interventions

All participants will undergo a 5-week period of medical optimisation as part of standard care. The 5 week medical optimisation includes ensuring adequate AF rate control using medical therapy (rate control medications) and optimising heart failure therapy and fluid status (i.e. using diuretics for fluid overload, ensuring guideline-directed therapies for heart failure are incorporated as tolerated). Medical optimisation within the study protocol does not differ from routine AF and heart failure

All participants will undergo a 5-week period of medical optimisation as part of standard care. The 5 week medical optimisation includes ensuring adequate AF rate control using medical therapy (rate control medications) and optimising heart failure therapy and fluid status (i.e. using diuretics for fluid overload, ensuring guideline-directed therapies for heart failure are incorporated as tolerated). Medical optimisation within the study protocol does not differ from routine AF and heart failure management. Management during this medical optimisation period follows routine clinical practice and does not differ from usual care. AF catheter ablation (AF ablation) Catheter ablation will be performed by a specialist Cardiac electrophysiologist using a standard ablation approach (this includes radiofrequency, cryoablation or pulsed field ablation, depending on local institutional practice) for atrial fibrillation. Following trans-septal access to the left atrium, electroanatomical mapping will be undertaken using a three-dimensional mapping system. Pulmonary vein isolation (PVI) will be performed, with delivery of ablation lesions to achieve electrical isolation of all pulmonary veins. Additional ablation (e.g. targeting non-pulmonary vein triggers or substrate modification) may be performed at the discretion of the treating operator in accordance with standard clinical practice. The procedure will be performed by a cardiac electrophysiologist (a cardiologist with specialist training in cardiac rhythm disorders and catheter ablation) in an accredited electrophysiology laboratory. The approximate procedure duration will be between 1-3 hours per participant, depending on institutional practice and ablation technology utilized. If allocated to ablation, the intervention (ablation) will be delivered as a single procedure during the the study period. Repeat ablation procedures may be performed if clinically indicated during follow-up, according to standard care. The procedure will be conducted in a hospital-based electrophysiology laboratory within participating tertiary referral centres.

Sponsors

Alfred Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age 18 years or older 2. Documented atrial fibrillation (paroxysmal or persistent) 3. Heart failure with mid-range or preserved left ventricular ejection fraction (LVEF 40% or above on echocardiography or cardiac MRI) 4. Symptoms attributable to atrial fibrillation and/or heart failure 5. Suitable candidate for both catheter ablation and medical rhythm control therapy as determined by the treating cardiologist 6. Receiving guideline-directed medical therapy for heart failure (as tolerated) 7. Able to provide written informed consent

Exclusion criteria

1. Contraindication to CMR (i.e. eGFR<25; 5 years deemed unlikely to restore or maintain sinus rhythm) 3. LVEF <40% 4. Other acute reversible cause of heart failure (uncontrolled thyroid disease, excessive alcohol, active myocarditis) 5. Planned alternate cardiac intervention within 12 months of enrolment (i.e. valvular intervention, coronary artery bypass graft surgery)

Outcome results

None listed

Source: ANZCTR · Data processed: May 1, 2026