Actively Recruiting
Comparative Study of Intra-abdominal Pressure Using Accuryn Monitoring System During Pulsed Field Ablation for Treatment of Atrial Fibrillation and/or Atrial Flutter Under Sedation
Led by Wake Forest University Health Sciences · Updated on 2026-03-19
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study intra-abdominal pressure (IAP) during pulsed field ablation (PFA) procedures in patients treated for atrial fibrillation or atrial flutter. The study compares changes in IAP and safety outcomes based on the type of anesthesia used during the procedure. Elevated IAP may relate to risks like aspiration and respiratory complications, and this study evaluates how different anesthetic methods affect these factors. Participants will have the Accuryn Foley catheter device placed, which continuously measures intra-abdominal pressure and urine output in real time. The study focuses on monitoring IAP during PFA under general anesthesia and sedation, assessing the procedure's safety and physiological responses using this FDA-cleared device. During the study, participants will be monitored for intra-abdominal pressure at two hours after PFA, along with secondary outcomes such as hiccups, oral secretions, post-operative intubations, urine output, urinary tract infections by day 7, and unplanned hospital admissions at two hours. This comprehensive monitoring aims to improve understanding of patient safety during PFA procedures, with the total study period extending up to the end date in 2026.
CONDITIONS
Brief Title
Intra-abdominal Pressure (IAP) During PFA Treatment of A-fib/ A-Flutter
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Procedure duration plus immediate post-operative period
Participants have the Accuryn Foley catheter placed to measure intra-abdominal pressure during their Pulsed Field Ablation procedure for atrial fibrillation and/or atrial flutter.
1 procedural visit (in-person)
Duration - Up to 7 days after the procedure
Participants are monitored for outcomes including intra-abdominal pressure changes, urinary output, and any post-operative complications such as urinary tract infections or unplanned hospital admissions.
1 follow-up visit within 7 days post-procedure
Trial Site Locations
Total: 1 location
1
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
K
Karuna Rajkumar, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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