Continuous belly pressure monitoring during pulsed field ablation for atrial fibrillation/flutter

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center interventional study uses the Accuryn Foley catheter to record continuous intra-abdominal pressure (IAP) and urine output during pulsed field ablation (PFA) procedures in adults with atrial fibrillation or atrial flutter. Participants will undergo standard-of-care PFA while investigators collect real-time IAP data and compare pressure patterns between different anesthetic approaches. The protocol excludes patients with recent intra-abdominal surgery, contraindications to bladder catheterization, pregnancy, and those with COPD on home oxygen. Investigators aim to correlate IAP changes with procedure-related risks such as aspiration or respiratory compromise and to determine whether anesthesia choice influences those responses.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Karuna Rajkumar, MD — Wake Forest University Health Sciences
• Study coordinator: Karuna Rajkumar, MD
• Email: kputturr@wakehealth.edu
• Phone: 832-707-0858

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.