Continuous belly pressure monitoring during pulsed field ablation for atrial fibrillation/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.
This will test whether using an Accuryn Foley catheter to continuously measure intra-abdominal pressure during pulsed field ablation can reveal pressure changes related to different types of anesthesia in adults treated for atrial fibrillation or atrial flutter.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT06876896 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults having clinically indicated pulsed field ablation for atrial fibrillation or atrial flutter who can safely receive a Foley catheter and have no recent intra-abdominal surgery or other contraindications to bladder catheterization.
Not a fit: Patients who are pregnant, unable to have bladder catheterization, have recent intra-abdominal surgery, frequent urinary infections or require home oxygen for COPD are unlikely to benefit or be eligible for this protocol.
Why it matters
Potential benefit: If successful, continuous IAP monitoring could help clinicians detect dangerous pressure rises during PFA and prompt interventions that reduce aspiration risk and unplanned admissions.
How similar studies have performed: Foley-based continuous IAP monitoring is FDA-cleared and used in surgical and critical care settings, but its specific use during PFA for atrial arrhythmias is a novel application with limited prior data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Winston-Salem, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.