RecruitingNot ApplicableNCT06876896
Intra-abdominal Pressure (IAP) During PFA Treatment of A-fib/ A-Flutter
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.
Sponsor
Wake Forest University Health Sciences
Enrollment
50 participants
Start Date
Mar 3, 2026
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria2
- 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 Criteria5
- 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
Interventions
DEVICEAccuryn Foley catheter device
Accuryn foley catheter placed on all subjects after consent who are having treatment for atrial flutter or atrial fibrillation
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06876896
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