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RECRUITINGINTERVENTIONAL

Intra-abdominal Pressure (IAP) During PFA Treatment of A-fib/ A-Flutter

Comparative Study of Intra-abdominal Pressure Using Accuryn Monitoring System During Pulsed Field Ablation (PFA) for Treatment of Atrial Fibrillation and/or Atrial Flutter Under Sedation.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

Accuryn Foley catheter device

Accuryn foley catheter placed on all subjects after consent who are having treatment for atrial flutter or atrial fibrillation

Locations (1)

Wake Forest Health Sciences
Winston-Salem, North Carolina, United States