Evaluating early catheter ablation for atrial fibrillation in heart failure patients
Danish Evaluation of Early Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure - The DanAblate-HF Trial
NA · Aalborg University Hospital · NCT06560047
This study is testing whether early catheter ablation for atrial fibrillation can help heart failure patients feel better compared to standard treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1616 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Aalborg University Hospital (other) |
| Locations | 6 sites (Aalborg and 5 other locations) |
| Trial ID | NCT06560047 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18 to 80 with heart failure and atrial fibrillation who meet specific clinical criteria.
Not a fit: Patients with reversible causes for atrial fibrillation or those who have previously undergone catheter ablation for AF may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with heart failure and atrial fibrillation, potentially improving their quality of life and reducing morbidity and mortality.
How similar studies have performed: While there is a growing interest in catheter ablation for AF in heart failure patients, this specific approach is still under investigation and lacks solid scientific evidence from previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aalborg and 5 other locations
- Aalborg University Hospital, Department of Cardiology — Aalborg, Denmark (RECRUITING)
- Aarhus University Hospital — Aarhus, Denmark (NOT_YET_RECRUITING)
- Department of Cardiology, Rigshospitalet — Copenhagen, Denmark (RECRUITING)
- Department of Cardiology, Herlev-Gentofte University Hospital — Hellerup, Denmark (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation, Heart Failure, Heart failure, Atrial fibrillation, Catheter ablation, Treatment, Outcome