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

Last updated: August 29, 2024
Sponsor: Aalborg University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Hyponatremia

Congestive Heart Failure

Treatment

Catheter ablation

Clinical Study ID

NCT06560047
N-20240001
F2024-063
  • Ages 18-80
  • All Genders

Study 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

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 forHFrEF, 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

  1. 18 years ≤ Age <80 years

  2. Optimal medical therapy for HFrEF or planned/current uptitration in guidelinedirected medical therapy for HFrEF

  3. Treatment with anticoagulation for stroke prevention, initiated according toguidelines for treatment of AF

Exclusion

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 3months

  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

Study Design

Total Participants: 1616
Treatment Group(s): 1
Primary Treatment: Catheter ablation
Phase:
Study Start date:
August 28, 2024
Estimated Completion Date:
August 31, 2039

Study Description

Atrial fibrillation (AF) is the most common arrhythmia in patients with heart failure (HF), with rates ranging between 20-65%, depending on age, severity of HF, subtypes of HF and duration of HF. The two conditions have an intricate and often overlapping pathophysiology, with each condition leading to development of the other, as well as progression of disease. Studies have shown that the presence of AF in HF patients is associated with increased morbidity and mortality, deterioration in HF, exacerbated HF symptoms, and reduced quality of life. The optimal treatment of AF in the presence of HF remains unknown. Currently, there is a pull towards catheter ablation as first-line therapy for AF in HF patients. However, there is no solid scientific evidence to support this approach. Furthermore, it is unknown whether early rhythm control by catheter ablation in HF patients is beneficial.

The investigators aim to conduct a pragmatic, randomized clinical trial designed to evaluate the efficacy and safety of early catheter ablation for AF in patients with HF compared with standard treatment.

Eligible patients with HF and AF will be prospectively screened from all Danish hospitals and randomized 1:1 to early catheter ablation with pulmonary vein isolation (within 6 weeks) or standard guideline directed treatment for AF. Patients with reversible causes for AF, conditions that preclude the use of catheter ablation or previous catheter ablation for AF will be excluded from the study. Randomization and follow-up will be conducted at six specialized sites in Denmark. There will be one scheduled on-site 12-months follow-up visit after randomization. All clinical follow-up will be conducted at the patient's local hospital, according to standard practice and out of trial setting. Information regarding hospital visits/admissions, events, adverse events, changes in medication, cross-over, heart rhythm and rate, and results of relevant blood-work will be ascertained through systematic patient chart-review at pre-specified time-points. The results from this trial will mold future treatment of AF in HF patients. The investigators hypothesize that early catheter ablation reduces the risk of HF hospitalizations and mortality when compared with standard treatment, thereby significantly improving the clinical prognosis for patients with HF and AF.

Connect with a study center

  • Aalborg University Hospital, Department of Cardiology

    Aalborg, 9000
    Denmark

    Active - Recruiting

  • Aarhus University Hospital

    Aarhus, 8200
    Denmark

    Site Not Available

  • Department of Cardiology, Rigshospitalet

    Copenhagen, 2100
    Denmark

    Active - Recruiting

  • Department of Cardiology, Herlev-Gentofte University Hospital

    Hellerup, 2900
    Denmark

    Active - Recruiting

  • Department of Cardiology, Odense University Hospital

    Odense, 5000
    Denmark

    Site Not Available

  • Department of Cardiology, Zealand University Hospital

    Roskilde, 4000
    Denmark

    Site Not Available

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