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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Accuryn Foley catheter device

    Device

    Accuryn foley catheter placed on all subjects after consent who are having treatment for atrial flutter or atrial fibrillation

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Accuryn Foley catheter placementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Intra-abdominal pressure under Pulsed Field Ablation (PFA) under general anesthesia

intra-abdominal pressure during PFA when general anesthetic is utilized

Time frame
hour 2
2

Intra-abdominal pressure under Pulsed Field Ablation (PFA) under sedation

intra-abdominal pressure during PFA when anesthesia is sedation

Time frame
hour 2

Secondary outcomes

1

Incidence of Hiccups

incidence of hiccups occurring during the planned procedure

Time frame
hour 2
2

Amount oral secretions

Amount of oral secretions

Time frame
hour 2
3

Number of post-operative intubations

Number of incidences requiring postoperative intubation after procedure

Time frame
hour 2
4

Total urine output

Total urine output

Time frame
hour 2

Other outcomes

Sponsors and contacts

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