Danish Evaluation of Early Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure
Recruiting · NCT06560047 · Interventional (participants receive a specific treatment) · Lead sponsor: Aalborg University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Catheter ablation
What this trial is about
The DanAblate-HF trial will investigate whether early catheter ablation treatment for atrial fibrillation in patients with heart failure is superior to standard treatment.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
- 18 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 criteria
- 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
Where it is running
6 locations listed.
- 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