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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
Accuryn Foley catheter device
DeviceAccuryn foley catheter placed on all subjects after consent who are having treatment for atrial flutter or atrial fibrillation
Treatment groups
Trial outcomes
Primary outcomes
Intra-abdominal pressure under Pulsed Field Ablation (PFA) under general anesthesia
intra-abdominal pressure during PFA when general anesthetic is utilized
Intra-abdominal pressure under Pulsed Field Ablation (PFA) under sedation
intra-abdominal pressure during PFA when anesthesia is sedation
Secondary outcomes
Incidence of Hiccups
incidence of hiccups occurring during the planned procedure
Amount oral secretions
Amount of oral secretions
Number of post-operative intubations
Number of incidences requiring postoperative intubation after procedure
Total urine output
Total urine output
Sponsors and contacts
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