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CASTLE-AF Clinical Trial

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 Results

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.

Castle AF Key Result 1

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.

Castle AF Key Result 2

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.

Castle AF Key Result 3

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 Details

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

Castle AF 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

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