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

Inclusion Criteria15

HF patients with AF within the past 12 months
HF is defined as all of the below (all must apply)
Clinically assessed Heart Failure with Reduced Ejection Fraction (HFrEF)
An indication for initiation or ongoing guideline directed medical therapy for HFrEF, according to current Heart Failure guidelines
LVEF \< 50% at any point during the past 12 months
AF is defined as one or more of the following:
A. Symptomatic AF, documented by ECG, Holter of CIED
B. Asymptomatic AF with one or more of the following:
Clinical indication for rhythm or rate control (documented by ECG, telemetry, Holter, CIED)
≥2 ECG detected AF episodes within 3 months (on separate dates)
Holter detected AF with a continuous duration of more than 6 hours
CIED detected AF with continuous duration \>24 hours
years ≤ Age \<80 years
Optimal medical therapy for HFrEF or planned/current uptitration in guideline directed medical therapy for HFrEF
Treatment with anticoagulation for stroke prevention, initiated according to guidelines for treatment of AF

Exclusion Criteria16

Life-expectancy \< 1 year
BMI \> 40
Contraindications or unacceptable side effects to rate limiting drugs AND amiodarone
LA size (indexed for BSA) \> 60 ml/m2 (volume) on echo within the last year
Documented persistent/permanent AF \> 1 year
Previous AF ablation/surgery
Reversible causes of AF (including, but not limited to, infection within 14 days, untreated thyroid disease, surgery)
Severe valvular disease
Acute myocardial infarction, cardiothoracic surgery or stroke within the past 3 months
Planned cardiothoracic surgery
Listed for heart transplant
Contraindications for anticoagulation therapy or catheter ablation
Severe kidney disease (CKD≥5)
Pregnancy
Patient unwilling to try medical therapy for AF
Patient unwilling/unable to give informed consent for study participation

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.