An interventional study of Accuryn Foley catheter device in Intra-Abdominal Hypertension, sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
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.
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.
71 studies on the registry are indexed under Intra-Abdominal Hypertension; 16 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 32 interventional studies indexed under Intra-Abdominal Hypertension.
Browse Intra-Abdominal Hypertension studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
foley catheter is made to measure intra-abdominal pressure
Device: Accuryn Foley catheter device
Accuryn foley catheter placed on all subjects after consent who are having treatment for atrial flutter or atrial fibrillation
Intra-abdominal pressure under Pulsed Field Ablation (PFA) under general anesthesia
intra-abdominal pressure during PFA when general anesthetic is utilized
Time frame: hour 2
Intra-abdominal pressure under Pulsed Field Ablation (PFA) under sedation
intra-abdominal pressure during PFA when anesthesia is sedation
Time frame: hour 2
Incidence of Hiccups
incidence of hiccups occurring during the planned procedure
Time frame: hour 2
Amount oral secretions
Amount of oral secretions
Time frame: hour 2
Number of post-operative intubations
Number of incidences requiring postoperative intubation after procedure
Time frame: hour 2
Total urine output
Total urine output
Time frame: hour 2
Number of urinary tract infections
Number of urinary tract infections in the week postoperatively
Time frame: day 7
Number of unplanned admissions to the hospital
Number of unplanned admissions to the hospital
Time frame: hour 2
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.
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Intra-Abdominal Hypertension →
Wake Forest University Health Sciences →