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Intra-abdominal Pressure (IAP) During PFA Treatment of A-fib/ A-Flutter
Recruiting
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.
Who can join
Ages 18 and older · All sexes
Full 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
About the study
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.
What is being tested
- Accuryn Foley catheter device (device)
Sponsor: Wake Forest University Health Sciences · Participants: 50 · Started: Mar 3, 2026
Contact the study team
- Karuna Rajkumar, MD · Phone: 832-707-0858
Official record on ClinicalTrials.gov — NCT06876896
Locations in the U.S.
| North Carolina | Wake Forest Health Sciences, Winston-Salem |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.