RecruitingNot ApplicableNCT06876896

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

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.


Sponsor

Wake Forest University Health Sciences

Enrollment

50 participants

Start Date

Mar 3, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is measuring abdominal pressure changes during pulse field ablation — a procedure that uses short electrical pulses to treat an irregular heartbeat called atrial fibrillation or atrial flutter — to see if abdominal pressure monitoring is a useful safety measure. **You may be eligible if...** - You are an adult (18 or older) - You are scheduled to receive pulse field ablation as standard treatment for atrial fibrillation or atrial flutter - You are able to have a Foley catheter (bladder catheter) placed safely **You may NOT be eligible if...** - You are under 18 - You have had abdominal surgery within the past 6 months - You have contraindications to bladder catheterization (such as prostate problems or frequent urinary tract infections) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAccuryn Foley catheter device

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


Locations(1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, United States

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NCT06876896


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