FDA advises on PCA (percutaneous catheter ablation) study design:
This article was originally published in Clinica
Executive Summary
The US FDA has issued a guidance on clinical study designs for percutaneous catheter ablation (PCA) for the treatment of atrial fibrillation. Given the many unknowns about this condition, the agency recommends as a primary endpoint freedom from symptomatic atrial fibrillation at one year, since it is relatively unambiguous.