RecruitingNot ApplicableNCT06560047

Danish Evaluation of Early Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure

Danish Evaluation of Early Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure - The DanAblate-HF Trial

Sponsor

Aalborg University Hospital

Enrollment

1,616 participants

Start Date

Aug 28, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure Atrial Fibrillation

Summary

The DanAblate-HF trial will investigate whether early catheter ablation treatment for atrial fibrillation in patients with heart failure is superior to standard treatment.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether catheter ablation (a procedure to restore normal heart rhythm) improves outcomes in patients with both heart failure and atrial fibrillation, compared to standard medication alone. **You may be eligible if...** - You are 18–79 years old with heart failure (reduced ejection fraction, LVEF below 50%) and atrial fibrillation within the past 12 months - You are on or working toward optimal heart failure medications - You are on anticoagulation (blood thinners) for stroke prevention **You may NOT be eligible if...** - Your life expectancy is less than 1 year - Your BMI is above 40 - You have contraindications to all rate-control medications and amiodarone - Your left atrium is very enlarged (indexed volume above 60 ml/m²) - You have had persistent/permanent atrial fibrillation for more than 1 year - You have had a prior AF ablation or cardiac surgery - Your AF is caused by a reversible trigger (like recent infection) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURECatheter ablation

Catheter ablation with pulmonary vein isolation will be the study intervention. Patients randomized to the intervention arm will undergo catheter ablation within six weeks of randomization. In the waiting-time for ablation, patients will receive standard treatment for AF and HF, as per current guideline recommendations. Catheter ablation will be performed at one of six high-volume ablation centers in Denmark. Mode of catheter ablation will be at the discretion of the operator. Radiofrequency ablation, cryo-balloon ablation and pulsed-field ablation will be utilized. The treating physician should ensure successful pulmonary vein isolation after ablation with either post-procedural mapping or pacing, as per current standards. Only pulmonary vein isolation will be performed during the ablation procedure.

Locations(6)

Aalborg University Hospital, Department of Cardiology

Aalborg, Denmark

Aarhus University Hospital

Aarhus, Denmark

Department of Cardiology, Rigshospitalet

Copenhagen, Denmark

Department of Cardiology, Herlev-Gentofte University Hospital

Hellerup, Denmark

Department of Cardiology, Odense University Hospital

Odense, Denmark

Department of Cardiology, Zealand University Hospital

Roskilde, Denmark

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NCT06560047

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