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 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 Result 2
Catheter ablation of atrial fibrillation in patients with heart failure is associated with a significant 47% reduction in 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.
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
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