Intra-Abdominal HypertensionIAPNCT06876896
Intra-abdominal Pressure (IAP) During PFA Treatment of A-fib/ A-Flutter
A study testing Accuryn Foley catheter device in people with Intra-Abdominal Hypertension, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra-Abdominal Hypertension
- What is being tested?
- Accuryn Foley catheter device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2026to 30 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
Karuna Rajkumar, 832-707-0858, kputturr@wakehealth.edu
About this study
Official 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.
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.
Read the 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.
- Conditions
- Intra-Abdominal Hypertension
- Being tested
- Accuryn Foley catheter device
- Keywords
- Atrial Fibrillation, Atrial Flutter, Pulsed Field Ablation
- Medical subject headings
- Intra-Abdominal Hypertension, Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accuryn Foley catheter deviceDevice
Accuryn foley catheter placed on all subjects after consent who are having treatment for atrial flutter or atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| Accuryn Foley catheter placement | Experimental | foley catheter is made to measure intra-abdominal pressure Receives: Device: Accuryn Foley catheter device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-abdominal pressure under Pulsed Field Ablation (PFA) under general anesthesia
intra-abdominal pressure during PFA when general anesthetic is utilized
Measured: hour 2
Intra-abdominal pressure under Pulsed Field Ablation (PFA) under sedation
intra-abdominal pressure during PFA when anesthesia is sedation
Measured: hour 2
Secondary outcomes (6)
Incidence of Hiccups
incidence of hiccups occurring during the planned procedure
Measured: hour 2
Amount oral secretions
Amount of oral secretions
Measured: hour 2
Number of post-operative intubations
Number of incidences requiring postoperative intubation after procedure
Measured: hour 2
Total urine output
Total urine output
Measured: hour 2
Number of urinary tract infections
Number of urinary tract infections in the week postoperatively
Measured: day 7
Number of unplanned admissions to the hospital
Number of unplanned admissions to the hospital
Measured: hour 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start3 Mar 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-Abdominal HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karuna Rajkumar, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876896
- Sponsor's protocol ID
- IRB00124904
- Acronym
- IAP
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No