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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 May 09, 2025

Not yet recruiting

Keywords

Atrial Fibrillation Atrial Flutter Pulsed Field Ablation

ClinConnect Summary

This clinical trial is looking at how pressure inside the abdomen changes during a specific heart procedure called pulsed field ablation, which is used to treat conditions like atrial fibrillation or atrial flutter. Researchers will use a special monitoring system called the Accuryn to measure this pressure while also considering the type of anesthesia used during the procedure. The goal is to better understand how these factors might relate to each other and ensure patient safety during treatment.

To participate in this study, you need to be an adult between the ages of 65 and 74 who is undergoing pulsed field ablation for heart issues. You must also be eligible for a specific type of catheter placement to measure abdominal pressure. However, individuals under 18 years old, those with certain recent surgeries, specific medical conditions, or who are pregnant or breastfeeding cannot take part in this trial. If you join, you can expect to have your abdominal pressure monitored during your procedure, which will help researchers learn more about this treatment and improve care for future patients.

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

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

Trial Officials

Karuna Rajkumar, MD

Principal Investigator

Wake Forest University Health Sciences

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported