Study of the Circa Scientific Rook Epicardial Access Kit for Safe and Effective Guidewire Access to the Hearts Outer Surface in Adults with Arrhythmia

What this Trial Is About

Researchers are evaluating the Circa Scientific Rook4 Epicardial Access Kit to see how well it can gain guidewire access to the outside surface of the heart, known as the epicardium. The study focuses on adult patients undergoing typical epicardial electrophysiology procedures and aims to confirm the devices safety and effectiveness compared to existing methods for epicardial access. This is a prospective, single-arm, non-randomized trial designed to assess performance and safety outcomes. Participants will receive treatment using the Rook4 Epicardial Access Kit, which accesses the epicardial surface through a subxiphoid approach to place a guidewire into the pericardial space. This device is used during the procedure, and there is only one study group receiving this treatment. The study will measure success in gaining epicardial access, speed of access, ease of use, and any device or procedure-related adverse events. During the study, researchers will confirm successful access to the pericardial space using standard x-ray techniques. Safety will be monitored up to hospital discharge or for up to four days after the procedure. Data on procedure speed, ease of use, and any errors will also be collected. Participants will be closely observed during the hospital stay to evaluate these outcomes and ensure safety throughout the process.

Epicardial Access Study With Rook