Intra-abdominal Pressure (IAP) During PFA Treatment of A-fib/ A-Flutter

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Accuryn Foley catheter device

Treatment groups

50 Participants
are divided into 1 treatment group