Recruiting
Intra-abdominal Pressure (IAP) During PFA Treatment of A-fib/ A-Flutter
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.
ClinicalTrials.gov IDNCT06876896
PhaseNA
Enrollment50
SponsorWake Forest University Health Sciences
Age18 Years
SexALL
Conditions studied
Intra-Abdominal Hypertension
About this 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.
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 outcomes
- Intra-abdominal pressure under Pulsed Field Ablation (PFA) under general anesthesia (hour 2)
- Intra-abdominal pressure under Pulsed Field Ablation (PFA) under sedation (hour 2)
Eligibility information
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
Study locations
- Wake Forest Health Sciences, Winston-Salem, North Carolina 27157 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.