NCT06560047 Danish Evaluation of Early Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure
| NCT ID | NCT06560047 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aalborg University Hospital |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,616 participants |
| Start Date | 2024-08-28 |
| Primary Completion | 2029-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,616 participants in total. It began in 2024-08-28 with a primary completion date of 2029-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Sam Riahi, MD, PhD
PRINCIPAL INVESTIGATOR
Department of Cardiology, Aalborg Univeristy Hospital
Frequently Asked Questions
Who can join the NCT06560047 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06560047 currently recruiting?
Yes, NCT06560047 is actively recruiting participants. Contact the research team at anne.christine.huth.ruwald@regionh.dk for enrollment information.
Where is the NCT06560047 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aarhus, Denmark, Copenhagen, Denmark, Hellerup, Denmark and 2 additional locations.
Who is sponsoring the NCT06560047 clinical trial?
NCT06560047 is sponsored by Aalborg University Hospital. The principal investigator is Sam Riahi, MD, PhD at Department of Cardiology, Aalborg Univeristy Hospital. The trial plans to enroll 1,616 participants.
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