Status:
NOT_YET_RECRUITING
Intra-abdominal Pressure (IAP) During PFA Treatment of A-fib/ A-Flutter
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Intra-Abdominal Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ty...
Detailed Description
Intra-abdominal pressure (IAP) may play a role in patient outcomes during ablation procedures, as increased IAP could indicate potential adverse events. Such adverse events include aspiration of stoma...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06876896
Start Date
March 1 2026
End Date
July 30 2026
Last Update
December 17 2025
Active Locations (1)
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1
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States, 27157