Safety and effectiveness of low-energy electrical cardioversion with or without bi-atrial pacing for treating post-operative atrial fibrillation during elective open chest cardiac surgery in adults

What this Trial Is About

This research investigates patients undergoing elective open chest cardiac surgery, including bypass and valve procedures, focusing on post-operative atrial fibrillation POAF. It is an observational, international registry study conducted in two phases to document standard care and assess the use of low-energy cardioversion and bi-atrial pacing in treating POAF. In Phase A, approximately 150 patients will be observed for standard post-operative pacing and treatment of POAF without using the DefiPace device. Data will be collected from surgery until hospital discharge, with follow-up phone calls 30 days post-surgery for those who develop POAF. Phase B will involve around 300 patients planned for TMA implantation during surgery, with 100 patients using the DefiPace system for low-energy cardioversion and bi-atrial pacing. Similar data collection and 30-day follow-up calls will occur in this phase. Participants will be monitored during their hospital stay with data collected on treatment and outcomes. Follow-up assessments via phone will occur 30 days after surgery for patients who develop POAF. Researchers will measure outcomes such as incidence and termination of POAF, time spent in POAF, number and energy of shocks, procedural success, time in intensive care, and time required for electrode placement. The study aims to gather real-world evidence on these treatments and their effects over this period.

The DefiPace Study