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Intra-abdominal Pressure During PFA Treatment for A-fib/A-Flutter

This study is looking at how a device called Accuryn Foley catheter measures pressure inside your belly (intra-abdominal pressure or IAP) during a heart procedure called pulsed field ablation (PFA). PFA is used to treat irregular heartbeats like atrial fibrillation (A-fib) or atrial flutter. Researchers want to see if the type of anesthesia you receive (general anesthesia or sedation) affects this pressure. Increased IAP could lead to problems like breathing issues after the procedure. You might be able to join if you are an adult having PFA for A-fib or A-flutter and can safely have a Foley catheter placed. The study will measure your IAP at the 2-hour mark to see if there are differences based on the anesthesia used.

Study design
This is an interventional study planning to enroll 50 participants. All participants will receive the Accuryn Foley catheter device.
What's involved
Participants will have an Accuryn Foley catheter placed after giving consent. Intra-abdominal pressure will be measured at the 2-hour mark.
Compensation
Not stated in the trial record.
Follow-up
Intra-abdominal pressure will be measured at the 2-hour mark after the procedure.

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NCT06876896

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

Recruiting
NAAges 18+InterventionalSupportive care
Wake Forest University Health Sciences
~50 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:Accuryn Foley catheter device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intra-abdominal pressure under Pulsed Field Ablation (PFA) under general anesthesia
Measured over hour 2
+1 more outcome measured

Conditions

Intra-Abdominal Hypertension

Explore related trials

Atrial FibrillationAtrial Flutter

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Karuna Rajkumar, MD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

Who to contact

Karuna Rajkumar, MD
[email protected]
832-707-0858
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Intra-abdominal pressure under Pulsed Field Ablation (PFA) under general anesthesiahour 2

    intra-abdominal pressure during PFA when general anesthetic is utilized

  • Intra-abdominal pressure under Pulsed Field Ablation (PFA) under sedationhour 2

    intra-abdominal pressure during PFA when anesthesia is sedation