Accuryn Foley Catheter Device for Atrial Tachycardia
(IAP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how the Accuryn Foley Catheter measures abdominal pressure during a heart procedure called pulsed field ablation. Researchers aim to determine how different types of anesthesia affect these pressure readings. The trial includes adults undergoing pulsed field ablation for irregular heartbeat conditions such as atrial fibrillation or atrial flutter, who can have a Foley catheter placed without complications. Participants should not have had recent abdominal surgery or certain urinary conditions. As an unphased trial, participants contribute to innovative research that could enhance future heart procedures.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the Accuryn Foley Catheter Device is safe for measuring intra-abdominal pressure?
Research has shown that the Accuryn Foley Catheter Device, which measures abdominal pressure, is generally well-tolerated. Collecting continuous, real-time data on abdominal pressure and urine output has been safely conducted in similar situations, suggesting the device's safety. Although specific data on side effects for this exact use is lacking, Foley catheters are commonly used in healthcare, supporting their safety. Prospective participants should discuss any concerns with their doctor.12345
Why are researchers excited about this trial?
Researchers are excited about the Accuryn Foley Catheter Device for atrial tachycardia because it introduces a novel approach by measuring intra-abdominal pressure. Unlike standard treatments for atrial tachycardia, which usually involve medications or ablation procedures to regulate heart rhythm, this device offers a potential non-invasive way to monitor and potentially influence heart health through pressure measurement. This innovative method could provide real-time data, helping to manage the condition more effectively and with potentially fewer side effects than traditional treatments.
What evidence suggests that the Accuryn Foley Catheter Device is effective for measuring intra-abdominal pressure during atrial tachycardia procedures?
Research has shown that the Accuryn Foley Catheter Device can continuously measure abdominal pressure and track urine output in real time. This real-time monitoring may enhance safety during medical procedures, such as pulsed field ablation, used to treat atrial tachycardia. Studies suggest that accurately tracking urine can help detect kidney problems early and improve patient health. The Accuryn system automates these measurements, potentially providing more reliable data than traditional methods. Although it is still under study for atrial tachycardia in this trial, its innovative monitoring approach holds promise for improving patient care.12346
Who Is on the Research Team?
Karuna Rajkumar, MD
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
This trial is for patients with atrial tachycardia or abdominal compartment syndrome. Specific eligibility criteria are not provided, so it's important to contact the study team for details on who can participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo Pulsed Field Ablation (PFA) with intra-abdominal pressure monitoring using the Accuryn system
Follow-up
Participants are monitored for safety and effectiveness after the procedure, including tracking of urinary tract infections and unplanned hospital admissions
What Are the Treatments Tested in This Trial?
Interventions
- Accuryn Foley Catheter Device
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor