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. 2016 Mar 4;594(9):2417–2430. doi: 10.1113/JP271660

Table 1.

Summary of the differences between clinical and modelling studies (examples of study design)

Clinical study Modelling study
Patient selection Group of patients satisfying inclusion/exclusion criteria Multiple variants of one or several models (modification of the substrate)
Indications for ablation Drug‐resistant paroxysmal or persistent AF AF episode of duration >10–30 s
Study design Same therapy in many patients Several therapies in the same model (or a few different models)
Statistics over patients Statistics over simulations in the same substrate
The substrate is sometimes characterised The substrate is specified
AF mechanism is studied AF mechanism is postulated and is an input to the model
Ablation procedure Step‐wise ablation Instantaneous application of all ablation lines
Procedure time Up to a few hours 2–30 s of simulation
Side effects Inflammation, risk of complications None simulated
Criteria for AF termination No AF after the procedure and until patient release AF termination within 2–30 s
Criteria for AF prevention No symptomatic AF episodes (48 h or several months of follow‐up) All induction attempts failed (ectopic in the pulmonary vein)
Access to physiological data ECG, electrical mapping All variables everywhere all the time
Reproducibility Limited by inter‐patient variability; AF episodes may vary in the same patient Yes; variability can be controlled
Unique features Real patient, real heart Validation is critical
Ablation is irreversible Possibility to ‘undo’ an ablation line and try another one
Risks for the patients, including mortality and morbidity No human life at risk

AF, atrial fibrillation.