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

Wake Forest University (WFU)

Status: Begins enrollment this month

Conditions: Intra-Abdominal Hypertension

Treatments: Device: Accuryn Foley catheter device

Study type: Interventional

Funder types: Other

Identifiers

NCT06876896

IRB00124904

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Accuryn Foley catheter placement

Experimental group

Description:

foley catheter is made to measure intra-abdominal pressure

Treatment:

Device: Accuryn Foley catheter device