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NCT06560047Recruiting

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

Danish Evaluation of Early Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure - The DanAblate-HF Trial

Source: ClinicalTrials.gov · Last updated 30 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The DanAblate-HF trial will investigate whether early catheter ablation treatment for atrial fibrillation in patients with heart failure is superior to standard treatment.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
1616 (estimated)
First submitted
15 Aug 2024
Start date
28 Aug 2024
Primary completion date
31 Aug 2029
Lead sponsor
Aalborg University Hospital
NCT number
NCT06560047

What you commit to

  • Study type: Interventional
  • Planned participants: 1616
  • From 28 Aug 2024 to the primary completion date, 31 Aug 2029
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contraindications or unacceptable side effects to rate limiting drugs AND amiodarone
  • Previous AF ablation/surgery
  • Planned cardiothoracic surgery
  • Contraindications for anticoagulation therapy or catheter ablation
  • Patient unwilling to try medical therapy for AF

Other illness

  • 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
  • Listed for heart transplant
  • Severe kidney disease (CKD≥5)

Other

  • Life-expectancy \< 1 year
  • BMI \> 40
  • LA size (indexed for BSA) \> 60 ml/m2 (volume) on echo within the last year
  • Documented persistent/permanent AF \> 1 year
  • Pregnancy
  • Patient unwilling/unable to give informed consent for study participation

Who the study is looking for

  • 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:
    • Symptomatic AF, documented by ECG, Holter of CIED
    • 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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aalborg University Hospital, Department of Cardiology
Coordinator of this site? Confirm its status
AalborgDenmarkRecruiting
Aarhus University Hospital
Coordinator of this site? Confirm its status
AarhusDenmarkNot yet recruiting
Department of Cardiology, Rigshospitalet
Coordinator of this site? Confirm its status
CopenhagenDenmarkRecruiting
Department of Cardiology, Herlev-Gentofte University Hospital
Coordinator of this site? Confirm its status
HellerupDenmarkRecruiting
Department of Cardiology, Odense University Hospital
Coordinator of this site? Confirm its status
OdenseDenmarkNot yet recruiting
Department of Cardiology, Zealand University Hospital
Coordinator of this site? Confirm its status
RoskildeDenmarkNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.