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New study monitors belly pressure during heart procedure to improve safety

NCT ID NCT06876896

Knowledge-focused Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how belly pressure changes during a heart procedure called pulsed field ablation for atrial fibrillation. Researchers will use a special catheter to measure pressure in the abdomen while patients are under different types of anesthesia. The goal is to see if the type of sedation affects belly pressure, which could help prevent complications. About 50 adults having standard treatment for AFib or atrial flutter will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Accuryn Foley catheter device
What this could lead to
If successful, this could help doctors better manage patient safety during heart ablation procedures by understanding how anesthesia affects abdominal pressure.
What could go wrong
This is a small, early observational study with only 50 participants, so results may not apply to all patients. It does not test a new treatment, only monitors a safety measure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atrial fibrillation atrial flutter Intra-Abdominal Hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intra-abdominal hypertension

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Wake Forest Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

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