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

RECRUITINGN/ASponsored by Aalborg University Hospital
Actively Recruiting
PhaseN/A
SponsorAalborg University Hospital
Started2024-08-28
Est. completion2029-08-31
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
Inclusion Criteria:

1. 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
2. 18 years ≤ Age \<80 years
3. Optimal medical therapy for HFrEF or planned/current uptitration in guideline directed medical therapy for HFrEF
4. Treatment with anticoagulation for stroke prevention, initiated according to guidelines for treatment of AF

Exclusion Criteria:

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

Conditions3

Atrial FibrillationHeart DiseaseHeart Failure

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