Status:
RECRUITING
Danish Evaluation of Early Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure
Lead Sponsor:
Aalborg University Hospital
Collaborating Sponsors:
Rigshospitalet, Denmark
Odense University Hospital
Conditions:
Atrial Fibrillation
Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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.
Detailed Description
Atrial fibrillation (AF) is the most common arrhythmia in patients with heart failure (HF), with rates ranging between 20-65%, depending on age, severity of HF, subtypes of HF and duration of HF. The ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2039
Estimated Enrollment :
1616 Patients enrolled
Trial Details
Trial ID
NCT06560047
Start Date
August 28 2024
End Date
August 31 2039
Last Update
August 30 2024
Active Locations (6)
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1
Aalborg University Hospital, Department of Cardiology
Aalborg, Denmark, 9000
2
Aarhus University Hospital
Aarhus, Denmark, 8200
3
Department of Cardiology, Rigshospitalet
Copenhagen, Denmark, 2100
4
Department of Cardiology, Herlev-Gentofte University Hospital
Hellerup, Denmark, 2900