Intra-abdominal Pressure (IAP) During PFA Treatment of A-fib/ A-Flutter
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Accuryn Foley catheter device.
- Who it may be relevant to
- Registry conditions: Intra-Abdominal Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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.
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.
Interventions
- Device Accuryn Foley catheter device
Accuryn foley catheter placed on all subjects after consent who are having treatment for atrial flutter or atrial fibrillation
Primary outcome measures
- Intra-abdominal pressure under Pulsed Field Ablation (PFA) under general anesthesia [Time frame: hour 2]
- Intra-abdominal pressure under Pulsed Field Ablation (PFA) under sedation [Time frame: hour 2]
Secondary outcome measures (6)
- Incidence of Hiccups [Time frame: hour 2]
- Amount oral secretions [Time frame: hour 2]
- Number of post-operative intubations [Time frame: hour 2]
- Total urine output [Time frame: hour 2]
- Number of urinary tract infections [Time frame: day 7]
- Number of unplanned admissions to the hospital [Time frame: hour 2]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Wake Forest Health Sciences — Winston-Salem
Identifiers
NCT: NCT06876896 · IRB00124904