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

N/ANot Yet RecruitingNCT06876896

Wake Forest University Health Sciences50 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Intra-Abdominal Hypertension

Interventions

Accuryn Foley catheter deviceDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Intra-abdominal pressure under Pulsed Field Ablation (PFA) under general anesthesia

intra-abdominal pressure during PFA when general anesthetic is utilized

Time frame: hour 2

Intra-abdominal pressure under Pulsed Field Ablation (PFA) under sedation

intra-abdominal pressure during PFA when anesthesia is sedation

Time frame: hour 2

Secondary Outcomes

Incidence of Hiccups

incidence of hiccups occurring during the planned procedure

Time frame: hour 2

Amount oral secretions

Amount of oral secretions

Time frame: hour 2

Number of post-operative intubations

Number of incidences requiring postoperative intubation after procedure

Time frame: hour 2

Total urine output

Time frame: hour 2

Number of urinary tract infections

Number of urinary tract infections in the week postoperatively

Time frame: day 7

Number of unplanned admissions to the hospital

Time frame: hour 2

Central Contacts

Karuna Rajkumar, MD

CONTACT

832-707-0858 kputturr@wakehealth.edu

Data from ClinicalTrials.gov

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