Clinical trial NCT06876896: Intra-abdominal Pressure (IAP) During PFA Treatment of A-fib/ A-Flutter
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intra-Abdominal Hypertension
Keywords: Atrial Fibrillation
Atrial Flutter
Pulsed Field Ablation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intra-abdominal pressure under Pulsed Field Ablation (PFA) under general anesthesia
timeFrame: hour 2
measure: Intra-abdominal pressure under Pulsed Field Ablation (PFA) under sedation
timeFrame: hour 2
Secondary outcomes:
measure: Incidence of Hiccups
timeFrame: hour 2
measure: Amount oral secretions
timeFrame: hour 2
measure: Number of post-operative intubations
timeFrame: hour 2
measure: Total urine output
timeFrame: hour 2
measure: Number of urinary tract infections
timeFrame: day 7
measure: Number of unplanned admissions to the hospital
timeFrame: hour 2
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Karuna Rajkumar, MD
role: PRINCIPAL_INVESTIGATOR
References: