Inconsistent EfficacyKey arrhythmia measures have not reliably improved in the same patients, calling into question whether observed benefits reflect a consistent treatment effect.
Medication ConfoundingBackground use or changes in anti-arrhythmic medications can create the appearance of efficacy in small cohorts, making true drug benefit difficult to assess without adjustment.
Safety Signal RiskA reported supraventricular tachycardia event in a patient raises concern about potential treatment-related risks and could amplify downside if additional safety issues emerge.