What parameters were studied in the Watchman FLX trial?

The Watchman FLX trial specifically focused on patients with atrial fibrillation (AF) who were at an increased risk of stroke, as indicated by their CHA2DS2-VASc scores, in order to evaluate the effectiveness and safety of the Watchman FLX device for Left Atrial Appendage Occlusion (LAAO). The inclusion of patients with a CHA2DS2-VASc score reflecting a substantial risk of stroke emphasizes the trial's goal of determining how well the device could potentially mitigate stroke risk in a higher-risk population.

The HAS-BLED score, which assesses bleeding risk in patients with these conditions, was also part of the evaluation criteria to ensure that the participants not only had a high risk of stroke but also that their bleeding risk was monitored. By focusing on these parameters, the trial gained critical insights into the efficacy and safety of LAAO procedures in a well-defined and relevant patient population.

This targeted approach contrasts with other options which suggest populations or characteristics not relevant to the study's objectives or outcomes, such as patients only with other types of cardiovascular disease, general populations without heart conditions, or individuals undergoing unrelated surgical procedures, none of which would appropriately address the effectiveness of LAAO for stroke prevention in atr