Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157, United States
Location status: Recruiting
NCT Number: NCT06876896
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Winston-Salem, North Carolina, 27157, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Accuryn foley catheter placed on all subjects after consent who are having treatment for atrial flutter or atrial fibrillation
Time frame: hour 2
intra-abdominal pressure during PFA when general anesthetic is utilized
Time frame: hour 2
intra-abdominal pressure during PFA when anesthesia is sedation
Time frame: hour 2
incidence of hiccups occurring during the planned procedure
Time frame: hour 2
Amount of oral secretions
Time frame: hour 2
Number of incidences requiring postoperative intubation after procedure
Time frame: hour 2
Total urine output
Time frame: day 7
Number of urinary tract infections in the week postoperatively
Time frame: hour 2
Number of unplanned admissions to the hospital
Contact information is provided by the study sponsor or research team.
Wake Forest University Health Sciences
Other
Comparative Study of Intra-abdominal Pressure Using Accuryn Monitoring System During Pulsed Field Ablation (PFA) for Treatment of Atrial Fibrillation and/or Atrial Flutter Under Sedation.
Acronym: IAP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06697717
Acute Respiratory Distress Syndrome (ARDS), Cardiovascular Diseases
Wuhan, Hubei, China
View Trial DetailsNCT05070572
Cardiovascular Diseases, Compartment Syndromes
Brooklyn, New York, United States
View Trial DetailsNCT07400666
Cardiovascular Diseases, Compartment Syndromes
View Trial DetailsNCT04286490
Acute Kidney Injury, Acute Respiratory Distress Syndrome
Grenoble, France
View Trial Details