Intra-abdominal Pressure (IAP) During PFA Treatment of A-fib/ A-Flutter
Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Mar 10, 2025
Trial Information
Current as of April 23, 2025
Not yet recruiting
Keywords
ClinConnect Summary
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 stomach contents, which can lead to respiratory issues post procedure and unplanned admission to the hospital post procedure. Potrero Medical has manufactured a foley based monitoring system that has been FDA cleared for the indication of measuring intra-abdominal pressure. The Accuryn monitor allows for continuous, real-time measurement of IAP and urine output, providing data that may enhance proce...
Gender
ALL
Eligibility criteria
- 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
Trial Officials
Karuna Rajkumar, MD
Principal Investigator
Wake Forest University Health Sciences
About Wake Forest University Health Sciences
Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Winston Salem, North Carolina, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported