Evaluating early catheter ablation for atrial fibrillation in heart failure patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The DanAblate-HF trial aims to determine if early catheter ablation for atrial fibrillation (AF) in patients with heart failure (HF) is more effective than standard treatment. This pragmatic, randomized clinical trial will enroll eligible patients from Danish hospitals and randomly assign them to receive either early catheter ablation or standard guideline-directed treatment. The study will focus on patients with heart failure and atrial fibrillation, assessing the efficacy and safety of the intervention within a 6-week timeframe. The trial seeks to fill the knowledge gap regarding the optimal treatment approach for AF in the context of HF.

Why it matters

Who can join: the full rules

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

Where it's running

• Aalborg University Hospital, Department of Cardiology
  Aalborg, Denmark Recruiting
• Department of Cardiology, Rigshospitalet
  Copenhagen, Denmark Recruiting
• Department of Cardiology, Herlev-Gentofte University Hospital
  Hellerup, Denmark Recruiting
• Aarhus University Hospital
  Aarhus, Denmark Not yet recruiting
• Department of Cardiology, Odense University Hospital
  Odense, Denmark Not yet recruiting
• Department of Cardiology, Zealand University Hospital
  Roskilde, Denmark Not yet recruiting

Study contacts

• Principal investigator: Sam Riahi, MD, PhD — Department of Cardiology, Aalborg Univeristy Hospital
• Study coordinator: Anne-Christine Ruwald, MD, PhD
• Email: anne.christine.huth.ruwald@regionh.dk
• Phone: +45 40177181

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.