Intra-abdominal Pressure (IAP) During PFA Treatment of A-fib/ A-Flutter
Start Date
3/3/2026
Completion Date
12/30/2026
Summary
The purpose of this study is to investigate the intra-abdominal pressure utilizing the Accuryn monitoring system during pulsed field ablation procedures in the electrophysiology lab compared to the type of anesthetic utilized.
Detailed Description
Intra-abdominal pressure (IAP) may play a role in patient outcomes during ablation procedures, as increased IAP could indicate potential adverse events. Such adverse events include aspiration of stomach contents, which can lead to respiratory issues post procedure and unplanned admission to the hospital post procedure. Potrero Medical has manufactured a foley based monitoring system that has been FDA cleared for the indication of measuring intra-abdominal pressure. The Accuryn monitor allows for continuous, real-time measurement of IAP and urine output, providing data that may enhance procedural safety and provide insights into any physiological responses unique to Pulsed Field Ablation (PFA). This study aims to compare PFA in terms of safety, efficacy, and IAP changes based on type of anesthesia received.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Accuryn Foley catheter device
Conditions
Locations
Wake Forest Health Sciences
Winston-Salem, North Carolina 27157
United States