Castle-AF

CASTLE-AF

Catheter Ablation Versus Standard Conventional Treatment in Patients with Left Ventricular Dysfunction and Atrial Fibrillation

Marrouche NF, Brachmann J et al., New England Journal of Medicine 2018

Study Design

  • Prospective, randomized, multicenter, international
  • Evaluated the effectiveness of catheter ablation of atrial fibrillation in patients with heart failure on mortality and morbidity when compared to medical treatment
  • 398 patients at 33 sites in Europe, USA, and Australia

Key Result 1

Catheter ablation of atrial fibrillation in patients with heart failure is associated with a significant 38% reduction in death or hospitalization for worsening heart failure.

Death or Hospitalization for Worsening Heart Failure

Key Result 2

Catheter ablation of atrial fibrillation in patients with heart failure is associated with a significant 47% reduction in death from any cause.

Death from Any Cause

Key Result 3

Catheter ablation of atrial fibrillation in patients with heart failure is associated with a significant 44% reduction in hospitalization for worsening heart failure.

Hospitalization for Worsening Heart Failure

Clinical Relevance

  • CASTLE-AF is the first large, randomized study providing clinical evidence that ablation of atrial fibrillation improves hard outcome parameters in heart failure patients
  • Catheter ablation for patients with heart failure and concomitant AF can be suggested as a first-line therapy, as early as possible during the course of heart failure
  • The results strongly indicate that catheter ablation of atrial fibrillation is a crucial element in managing advanced heart failure, next to CRT and continuous remote monitoring
Study Objective
  • Evaluation of the effectiveness of catheter ablation of atrial fibrillation in patients with heart failure on mortality and morbidity when compared to medical treatment
Primary Endpoint
  • All-cause mortality or worsening of heart failure requiring unplanned hospitalization
Major Secondary Endpoints
  • All-cause mortality
  • Worsening of heart failure requiring unplanned hospitalization
  • Cerebrovascular accidents
  • Cardiovascular mortality
  • Unplanned hospitalization due to cardiovascular reason
  • All-cause hospitalization
  • Quality of Life: Minnesota Living with Heart Failure and EuroQoL EQ-5D
  • Exercise tolerance (6 minutes walk test)
Clinical Sites
  • 33 sites in Europe, USA, and Australia
Sample Size
  • 398 patients
Main Inclusion Criteria
  • Symptomatic paroxysmal or persistent AF
  • Failure or intolerance of antiarrhythmic drug therapy or unwillingness to take antiarrhythmic drugs
  • Left ventricular dysfunction with LVEF ≤ 35 % (measured in the last 6 weeks prior to enrollment)
  • NYHA class ≥ II
  • ICD for primary or secondary prevention with atrial sensing capabilities or CRT-D device, both with Home Monitoring® technology already implanted
Main Exclusion Criteria
  • Documented left atrial diameter > 6 cm
  • Contraindication for chronic anticoagulation therapy or heparin
  • Previous left heart ablation procedure for atrial fibrillation
  • Acute coronary syndrome, cardiac surgery, angioplasty or stroke within 2 months prior to enrollment
  • Untreated hypothyroidism or hyperthyroidism
  • Listed for heart transplant
  • Cardiac assist device implanted
  • Planned cardiovascular intervention
Study Flowchart
    Follow-Up
    • Follow-up visits at 3, 6, 12, 24, 36, 48, and 60 months after baseline (5 weeks after enrollment)
    Study Duration
    • January 2008 – January 2016
    Reference no.
    • NCT00643188 (ClinicalTrials.gov)
    Principal Investigators
    • Dr. Johannes Brachmann, Klinikum Coburg, Germany
    • Dr. Nassir F. Marrouche, University of Utah, USA
    Castle-AF results overview
    Castle-AF website

    For more information visit the Castle-AF website