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NCT Number: NCT06876896

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

Location contact

Karuna Rajkumar

CONTACT

[email protected]

832-707-0858

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accuryn Foley catheter device

Device

Accuryn foley catheter placed on all subjects after consent who are having treatment for atrial flutter or atrial fibrillation

Primary outcomes

  1. Intra-abdominal pressure under Pulsed Field Ablation (PFA) under general anesthesia

    Time frame: hour 2

    intra-abdominal pressure during PFA when general anesthetic is utilized

  2. Intra-abdominal pressure under Pulsed Field Ablation (PFA) under sedation

    Time frame: hour 2

    intra-abdominal pressure during PFA when anesthesia is sedation

Secondary outcomes

  1. Incidence of Hiccups

    Time frame: hour 2

    incidence of hiccups occurring during the planned procedure

  2. Amount oral secretions

    Time frame: hour 2

    Amount of oral secretions

  3. Number of post-operative intubations

    Time frame: hour 2

    Number of incidences requiring postoperative intubation after procedure

  4. Total urine output

    Time frame: hour 2

    Total urine output

  5. Number of urinary tract infections

    Time frame: day 7

    Number of urinary tract infections in the week postoperatively

  6. Number of unplanned admissions to the hospital

    Time frame: hour 2

    Number of unplanned admissions to the hospital

Study contacts

Contact information is provided by the study sponsor or research team.

Karuna Rajkumar, MD

CONTACT

[email protected]

832-707-0858

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 14, 2025
Registry last updated
Mar 19, 2026

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.

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