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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06876896
- Acronym / sponsor ID
- IAP / IRB00124904
- Conditions
- Intra-Abdominal Hypertension
- Keywords
- Atrial Fibrillation, Atrial Flutter, Pulsed Field Ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accuryn Foley catheter placement | Experimental | Device: Accuryn Foley catheter devicefoley catheter is made to measure intra-abdominal pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accuryn Foley catheter deviceAccuryn foley catheter placed on all subjects after consent who are having treatment for atrial flutter or atrial fibrillation | Device | Accuryn Foley catheter placement |
Primary outcome
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
Intra-abdominal pressure under Pulsed Field Ablation (PFA) under sedation
Time frame: hour 2
intra-abdominal pressure during PFA when anesthesia is sedation
6 secondary outcomes
Incidence of Hiccups
Time frame: hour 2
Amount oral secretions
Time frame: hour 2
Number of post-operative intubations
Time frame: hour 2
Total urine output
Time frame: hour 2
Number of urinary tract infections
Time frame: day 7
Number of unplanned admissions to the hospital
Time frame: hour 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Intra-Abdominal Hypertension
Enrolling by invitationObservational study
WSACS 2026 Delphi Consensus on the Practical Management of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
Intra-Abdominal Hypertension, Abdominal Compartment Syndrome
Not yet recruitingObservational study
From Blast Injury to Multicompartment Dysfunction:
Compartment Syndrome, Compartment Syndrome Nontraumatic Lower Extremity
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
Not yet recruitingObservational study
Cumulative Intra-Abdominal Pressure Burden and Acute Kidney Injury After Emergency Abdominal Surgery
Acute Kidney Injury, Intra-Abdominal Hypertension
RecruitingObservational study
Intra-Abdominal Pressure Changes During Continuous Renal Replacement Therapy in Critically Ill Patients
Intra-Abdominal Hypertension, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karuna Rajkumar, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karuna Rajkumar, MD (832-707-0858, kputturr@wakehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-abdominal pressure under Pulsed Field Ablation (PFA) under general anesthesia (time frame: hour 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.