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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Intra-Abdominal Hypertension
• Intervention / Treatment: Device: Accuryn Foley catheter device

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karuna Rajkumar, MD; Phone Number: 832-707-0858; Email: kputturr@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest Health Sciences
      • Contact: Karuna Rajkumar; Phone Number: 832-707-0858; Email: kputturr@wakehealth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Accuryn Foley catheter placement; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-abdominal pressure under Pulsed Field Ablation (PFA) under general anesthesia	intra-abdominal pressure during PFA when general anesthetic is utilized	hour 2
Intra-abdominal pressure under Pulsed Field Ablation (PFA) under sedation	intra-abdominal pressure during PFA when anesthesia is sedation	hour 2

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Karuna Rajkumar, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 14, 2025

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Atrial Flutter; Pulsed Field Ablation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Compartment Syndromes; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Atrial Flutter; Intra-Abdominal Hypertension
• Other Study ID Numbers: IRB00124904

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No