Intra-abdominal Pressure (IAP) During PFA Treatment of A-fib/ A-Flutter

Not Applicable

Not yet recruiting

• Conditions: Intra-Abdominal Hypertension

• Registration Number: NCT06876896
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-10
• Last Update Submitted: 2025-03-10
• Study First Posted: 2025-03-14
• Last Update Posted: 2025-03-14
• Study Start: 2025-06-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Adult patients receiving pulse field ablation procedures for standard of care treatment of atrial fibrillation and/or atrial flutter.
• Eligible for Foley catheter placement with no contraindications to Intra-abdominal pressure (IAP) monitoring.

Exclusion Criteria

• Patients under the age of 18 will be excluded.
• History of intra-abdominal surgery within the past 6 months.
• Known contraindications to bladder catheterization or catheter ablation; history of prostate issues / Benign prostatic hyperplasia (BPH) or frequent urinary tract infections
• Pregnant or breastfeeding individuals
• History of chronic obstructive pulmonary disease (COPD) with home oxygen use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Intra-abdominal pressure under Pulsed Field Ablation (PFA) under general anesthesia	hour 2	intra-abdominal pressure during PFA when general anesthetic is utilized
Intra-abdominal pressure under Pulsed Field Ablation (PFA) under sedation	hour 2	intra-abdominal pressure during PFA when anesthesia is sedation

Secondary Outcome Measures

Name	Time	Method
Incidence of Hiccups	hour 2	incidence of hiccups occurring during the planned procedure
Amount oral secretions	hour 2	Amount of oral secretions
Number of post-operative intubations	hour 2	Number of incidences requiring postoperative intubation after procedure
Total urine output	hour 2	Total urine output
Number of urinary tract infections	day 7	Number of urinary tract infections in the week postoperatively
Number of unplanned admissions to the hospital	hour 2	Number of unplanned admissions to the hospital

Trial Locations

Locations (1)

Wake Forest Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States