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Search / Trial NCT06876896

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

Atrial Fibrillation Atrial Flutter Pulsed Field Ablation

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.

Locations

Winston Salem, North Carolina, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported