Intra-abdominal Pressure (IAP) During PFA Treatment of A-fib/ A-Flutter
Recruiting · NCT06876896 · Interventional (participants receive a specific treatment) · Lead sponsor: Wake Forest University Health Sciences
View the official record on ClinicalTrials.gov →Interventions studied
Accuryn Foley catheter device
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Wake Forest Health Sciences - Winston-Salem, North Carolina, United States